Sep 25

Time to Approval and the Metrics of Facilitated Regulatory Pathways

By Dr. Jack Snyder, RAC (US, EU, CA, GS), Asst. Managing Director and Clinical Research Physician at Cato Research

“Early access pathways” for biomedical product marketing approval have attracted substantial attention recently, as Sarepta Therapeutics’ drug Exondys (eteplirsen) gained accelerated approval based on clinical data from just 12 patients.  In the United States, four “expedited” or “conditional” pathways for novel products for serious diseases or unmet medical need are available: Fast Track designation (FT), Breakthrough Therapy designation (BTD), Priority Review designation (PR), and Accelerated Approval pathway (AA).  Characteristics and distinguishing elements of these pathways have been well described by FDA in a 2014 Guidance for Industry: Expedited Programs for Serious Conditions — Drugs and Biologics. Proposed benefits include increased levels of communication and commitment between FDA and product sponsors, greater roles for surrogate endpoints, transfer of burden of evidence generation from pre- to post-authorization phases, and shortened review timelines. None of these programs are exclusive, any combination is permissible, and any designation may be rescinded if products do not continue to meet defined criteria upon periodic reassessment.

Some voices now are clamoring for FDA to adopt the approach of the European Medicines Agency (EMA), which instituted Conditional Marketing Authorization (CMA) procedures in 2006 for products where (a) benefit/risk balance is positive; (b) it is likely that comprehensive clinical data will be provided; (c) unmet medical needs will be fulfilled; and

(d) benefit to public health of immediate availability outweighs risks that additional data are still required.  These EMA-CMA approvals require annual renewal and can be converted to full marketing authorizations upon review of definitive data generated during the conditional approval period.

Do any of these initiatives significantly alter timelines in biomedical product development?  A group of European investigators recently assessed the influence of “Facilitated Regulatory Pathways” (FRP) on review times for 125 new active substances approved by FDA between January 2013 and December 2015.  Metrics for this study included the following:

 

Approved NAS 125
NAS approved using FRP 74 (no use of BTD alone, FT + BTD, or AA ± BTD)
Median development times (IND to NDA submission
Any FRP 2377 days
No FRP 2148 days
BTD + PR + AA 1458 days
FT alone 2620 days
PR alone 3515 days
Median Approval Times
Any FRP 243 days
No FRP 365 days
FT + BTD + PR + AA [a] 145 days
BTD + AA + PR 166 days
FT + BTD + PR 242 days
FT + PR 292 days
PR alone 242 days
Median Developmental + Approval Times (IND to Approval)
Any FRP 2620 days
No FRP 2513 days
BTD + AA + PR 1624 days
BTD + FT + PR 1720 days
FT + PR 2308 days
FT + BTD + AA + PR 2434 days
FT alone 2981 days
PR alone 3757 days

AA = Accelerated Approval; BTD = Breakthrough Therapy Designation; FRP = facilitated regulatory pathways; FT = Fast Track Designation; PR = Priority Review; NAS = new active substances
[a] Four NAS qualified for all four FRPs: ibrutinib, idelalisib, nivolumab, osimertinib mesylate, daratumumab

The authors concluded that combinations of FRPs can shorten review times beyond those provided by PR alone.  The data do not appear, however, to support a general conclusion that various combinations of FRPs reliably shorten the time elapsing between IND submission and marketing approval, or between product conception and marketing approval.

Although FRPs aim to accelerate patient access to medicines, some analyses have in fact shown that development times from first-in-human testing to marketing authorization using FRPs are comparable to development times associated with full (no FRP) marketing authorization, yet are based on less comprehensive data.  Consequently, commentators have raised the possibility that instead of using the FRPs prospectively, sponsors are using them as a backup to full authorization when data packages may not be strong enough to support a full market authorization through conventional pathways.  In any case, more data are needed to determine whether or not implementation of FRPs makes a meaningful difference in terms of conservation of time and/or resources in the biomedical product development plus approval process.

Meanwhile, as of June 2017, the same drug can be eligible for FRPs simultaneously in the U.S., Canada, Europe and Australia.  Since most countries in South America, Africa and Asia grant preferential review to drugs approved by regulators in the U.S., Canada, Europe and Australia, expedited approval in these regions potential translates into world-wide approval of a given drug. With multinational adoption of most expedited approval pathways, it may be tempting for sponsors to simultaneously apply for designations in all regions. However, if any one regulatory agency disagrees with the designation request, it is likely that other regulators will follow suit as well. So, the best strategy is to get successful designation in one region and then try to use that in others.

 

FDA facilitated regulatory pathways: Visualizing their characteristics, development, and authorization timelines. Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. Front Pharmacol. 2017 Apr; 8:1-6.

Use of the conditional marketing authorization pathway for oncology medicines in Europe.
Hoekman J, Boon WP, Bouvy JC, Ebbers HC, de Jong JP, De Bruin ML.
Clin Pharmacol Ther. 2015 Nov; 98(5):534-41.

Duchenne muscular dystrophy drugs at the crossroads, as newer agents advance.
Sheridan C.  Nat Biotechnol. 2016 Jul 12; 34(7):675-6.

 

Sep 08

New FDA Guidances for August 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in August 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices – Final Guidance 31 Aug 2017
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices – Draft Guidance 31 Aug 2017
FY 2018 Medical Device User Fee Small Business Qualification and Certification – Final Guidance 29 Aug 2017
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry – Draft Guidance 18 Aug 2017
Qualification of Medical Device Development Tools – Final Guidance 10 Aug 2017
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products – Final Guidance 08 Aug 2017
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports – Draft Guidance 08 Aug 2017
Child-Resistant Packaging Statements in Drug Product Labeling – Draft Guidance 02 Aug 2017
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Final Guidance 01 Aug 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Emergency Investigational New Drug Application Process During and After Normal Business Hours 17 Aug 2017
Upcoming Meetings (* = New)
* September 8, 2017: Medical Imaging Drugs Advisory Committee
* September 11, 2017: Pediatric Advisory Committee
* September 12, 2017: Pediatric Advisory Committee
* September 13, 2017: Vaccines and Related Biological Products Advisory Committee
* September 14, 2017: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee
* September 19, 2017: Oncologic Drugs Advisory Committee
* Meeting of the Peripheral and Central Nervous System Advisory Committee
  October 11-12, 2017: Patient Engagement Advisory Committee
* December 7, 2017: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
Last updated: 31 August 2017

Aug 16

What’s New Health Canada?

By Sandra Salem, Ph.D., Regulatory Scientist I, Cato Research

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 Health Canada New Guidance Documents (Drugs and Biologics)

Health Canada Guidance Type Date Posted
N/A

 

Updates from Health Canada (Drugs and Biologics) 

Type of Update and Link Date Posted
Updated: Questions and Answers for the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format 29 June 2017
Consultation on Proposed Modification to Bioequivalence Standards for Multiphasic Modified-Release Drug Products 27 July 2017
Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format 28 July 2017

 

  

 

Santé Canada: Quoi de neuf?

Par Sandra Salem, Ph.D., Scientifique Règlementaire I 

Quoi de neuf :

Direction des produits thérapeutiques

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/quoi-neuf-medicaments-sante-canada.html

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques) 

Ligne directrice de Santé Canada Genre Date
N/A

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques) 

Genre de mise à jour et lien Date
Mise à jour : Questions et réponses à propos de la ligne directrice à l’intention de l’industrie : Préparation de présentations de drogue en format CTD électronique (eCTD) 29 juin 2017
Consultation Modifications proposes aux norms en matière de bioéquivalence pour les produits pharmaceutiques à libération modifiée multiphasique 27 juillet 2017
Avis : Règles de validation des transactions réglementaires envoyées à Santé Canada en format « électronique autre que le format eCTD » 28 juillet 2017

 

Aug 14

New FDA Guidances for July 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in July 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Consumer Antiseptic Wash Final Rule – Questions and Answers– Final Guidance 25 July 2017
M4E(R2): The CTD – Efficacy– Final Guidance 24 July 2017
Maintenance Procedures for Q3C– Final Guidance 24 July 2017
PDE for Triethylamine and Methylisobutylketone– Final Guidance 24 July 2017
Q3C – Tables and List– Final Guidance 24 July 2017
ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents– Final Guidance 24 July 2017
IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects– Final Guidance 13 July 2017
Bioequivalence Recommendations for Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Dabigatran Etexilate Mesylate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Aspirin; Omeprazole– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Tenofovir Alafenamide Fumarate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Uridine Triacetate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Obeticholic Acid– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Dorzolamide Hydrochloride– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Brimonidine Tartrate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Fluphenazine Hydrochloride– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Glycopyrrolate Inhalation Powder– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Aspirin– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Diclofenac Sodium– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Brivaracetam– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Silver Sulfadiazine– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Triamcinolone Acetonide (ointment)– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Cyanocobalamin– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Triamcinolone Acetonide (lotion)– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Tiopronin– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Clocortolone Pivalate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Gefitinib– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Tipiracil Hydrochloride; Trifluridine– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Dextroamphetamine Sulfate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Gentamicin Sulfate – Draft Guidance 11 July 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Office of Biotechnology Products and Office of Process and Facilities, Interactions on BLA Assessments 26 July 2017
Communicating Drug Approval Information 17 July 2017
Upcoming Meetings (* = New)
  August 2, 2017: Meeting of the Arthritis Advisory Committee
* August 3, 2017: Meeting of the Arthritis Advisory Committee
* October 11-12, 2017: Meeting of the Patient Engagement Advisory Committee
Last updated: 1 August 2017

 

 

Jul 14

FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

Greg Hileman, Ph.D., Sr. Director and Principle Regulatory Scientist of Cato Research

The International Conference on Harmonization (ICH) last updated its guidance “THE CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS (ICH E14 (R3)) in 2005. This month, FDA published the most recent ICH updated list of questions and answers (ICH E14 Q&As ()) related to ICH E14, effectively making it an FDA guidance.  R3 included an updated question on the use of concentration-response modeling in lieu of point estimate and confidence interval calculation at Cmax. Important considerations when using modeling include the possibility of pooling data across multiple studies to explore a wider range of exposures than a single thorough QT prolongation study could explore while maintaining a focus on ECG quality and managing trial heterogeneity.  If data are available to estimate QT effects at sufficiently high multiples of clinically relevant exposures, a separate positive control may not be required.  As always, the focus of the analysis is to exclude a change of 10 ms or more (upper limit of the 90% confidence interval) at relevant concentrations. Significant savings with valid concentration-response modeling may result from predicting results at regimens not studied. A sponsor may be able to avoid certain intrinsic (enzyme induction or inhibition) and extrinsic (DDI) studies by predicting QTc effects.  High quality models may aid in deciding inclusion/exclusion criteria or in predicting dose adjustments needed in phase 3 and 4 studies where such factors are encountered.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073161.pdf

”ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) – questions and answers”

Jul 10

New FDA Guidances for June 2017

By Michelle Villasmil, Ph.D., RAC (US), Regulatory Scientist at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH and Manual of Policies and Procedures (MAPPs) of interest released from CDER in June 2017 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry – Draft Guidance 30 June 2017
Current Good Manufacturing Practice for Medical Gases – Draft Guidance 28 June 2017
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Final Guidance 27 June 2017
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Draft Guidance 20 June 2017
ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions – Draft Guidance 19 June 2017
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) – Revision 13 June 2017
Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions – Final Guidance 07 June 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Acceptance Criteria for Residual Solvents 28 June 2017
Prioritization of the Review of Original ANDAs, Amendments, and Supplements 27 June 2017
Review of Bioequivalence Studies with Clinical Endpoints in ANDAs 22 June 2017
NDAs/BLAs: Financial Disclosure  21 June 2017
Upcoming Meetings (* = New)
* July 11, 2017: Meeting of the Oncologic Drugs Advisory Committee
* July 12, 2017: Meeting of the Oncologic Drugs Advisory Committee
* July 13, 2017: Meeting of the Oncologic Drugs Advisory Committee
  July 28, 2017: Vaccines and Related Biological Products Advisory Committee Meeting
* August 2, 2017: Meeting of the Arthritis Advisory Committee Meeting
Last updated: 3 July 2017

Jun 19

What's New Health Canada? April – May 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy

 

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

 

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

 

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

 

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

 

Health Canada New Guidance Documents (Drugs and Biologics)

 

Health Canada Guidance Type Date Posted
Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements Guidance Document 01 May 2017

 

Updates from Health Canada (Drugs and Biologics)

 

Type of Update and Link Date Posted
Product Monograph Brand Safety Updates 17 May 2017
Notice to Stakeholders: Release of the Product Monograph Template – Schedule D – Biosimilar Biologic Drug 15 May 2017
Updated Master File (MF) Application Fee Form For Human Drugs 01 May 2017
Notice: Release of the Final Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements 28 Apr 2017
Notice Mandatory use of the Electronic Common Technical Document (eCTD) format 24 Apr 2017
Drug Product Database (DPD) Terminology   12 Apr 2017

 

Santé Canada: Quoi de neuf?

 

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie réglementaire

 

Quoi de neuf :

Direction des produits thérapeutiques

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-fra.php

 

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

 

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

 

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 

Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques)

 

Ligne directrice de Santé Canada Genre Date
Ligne directrice – Fiches maîtresses (FM) – Procédures et exigences administratives Ligne Directrice 01 mai 2017

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques)

 

Genre de mise à jour et lien Date
L’innocuité des monographies de produits pour les médicaments innovateurs 17 mai 2017
Avis à l’intention des intervenants : Publication du Modèle de monographie de produit – Annexe D – Médicament biologique biosimilaire 15 mai 2017
Mise à jour – Formulaire sur les frais pour Fiche maîtresses du médicament (FMM) 01 mai 2017
Avis : Publication de la version finale de la ligne directrice : Fiches maîtresses (FM) – Procédures et exigences administratives 28 avr. 2017
Avis – Utilisation obligatoire du format Electronic Common Technical Document (eCTD) 24 avr. 2017
Base de données sur les produits pharmaceutiques (BDPP) 12 avr. 2017

 

Jun 19

What’s New Health Canada? April – May 2017

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy

 

What’s New in:

Therapeutic Products Directorate:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/what-new-drug-products-health-canada.html

 

Biologics and Genetic Therapies Directorate:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php

 

Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html

 

Natural and Non-prescription Health Products Directorate: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html

 

 

Health Canada New Guidance Documents (Drugs and Biologics)

 

Health Canada Guidance Type Date Posted
Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements Guidance Document 01 May 2017

 

Updates from Health Canada (Drugs and Biologics)

 

Type of Update and Link Date Posted
Product Monograph Brand Safety Updates 17 May 2017
Notice to Stakeholders: Release of the Product Monograph Template – Schedule D – Biosimilar Biologic Drug 15 May 2017
Updated Master File (MF) Application Fee Form For Human Drugs 01 May 2017
Notice: Release of the Final Guidance Document: Master Files (MFs) – Procedures and Administrative Requirements 28 Apr 2017
Notice Mandatory use of the Electronic Common Technical Document (eCTD) format 24 Apr 2017
Drug Product Database (DPD) Terminology   12 Apr 2017

 

Santé Canada: Quoi de neuf?

 

Par Amélie Rodrigue-Way, Ph.D., RAC (CAN), Directrice associée, Stratégie réglementaire

 

Quoi de neuf :

Direction des produits thérapeutiques

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/update-miseajour/index-fra.php

 

Direction des produits biologiques et thérapies génétiques:

http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php

 

Instruments médicaux: https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html

 

Direction des produits de santé naturels et sans ordonnance:

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html

 

Nouvelles lignes directrices de Santé Canada (Médicaments et Produits biologiques)

 

Ligne directrice de Santé Canada Genre Date
Ligne directrice – Fiches maîtresses (FM) – Procédures et exigences administratives Ligne Directrice 01 mai 2017

 

Mises à jour de Santé Canada (Médicaments et Produits biologiques)

 

Genre de mise à jour et lien Date
L’innocuité des monographies de produits pour les médicaments innovateurs 17 mai 2017
Avis à l’intention des intervenants : Publication du Modèle de monographie de produit – Annexe D – Médicament biologique biosimilaire 15 mai 2017
Mise à jour – Formulaire sur les frais pour Fiche maîtresses du médicament (FMM) 01 mai 2017
Avis : Publication de la version finale de la ligne directrice : Fiches maîtresses (FM) – Procédures et exigences administratives 28 avr. 2017
Avis – Utilisation obligatoire du format Electronic Common Technical Document (eCTD) 24 avr. 2017
Base de données sur les produits pharmaceutiques (BDPP) 12 avr. 2017

 

Jun 05

New FDA Guidances for May 2017

By Sheila Plant, Ph.D., R.A.C., Assistant Director, Regulatory Strategy, US at Cato Research
One revised draft FDA guidance, released from CBER, and two MAPPs, released from CDER, in May 2017, are posted.  In addition, upcoming advisory committee meetings to be held in June and July are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Corrected Draft Guidance May 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
CDER FTE Tracking and Table of Organization Review Process 30 May 2017
Good Review Practice: Clinical and Consultative Review of Drugs to Reduce the Risk of Cancer 16 May 2017
Upcoming Meetings (* = New)
* June 20, 2017: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting
* June 21-22, 2017: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting
* July 28, 2017: Vaccines and Related Biological Products Advisory Committee Meeting
Last updated: 1 May 2017

May 08

New FDA Guidances for March and April 2017

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH, and Manual of Policies and Procedures (MAPPs) of interest, released from CDER in March and April are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

Special Interest Guidances/Information Date Posted
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles – Draft Guidance 24 Apr 2017
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Final Guidance 07 Apr 2017
Delayed Graft Function in Kidney Transplant: Developing Drugs for Prevention: Guidance for Industry – Draft Guidance 22 Mar 2017
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (Expiration date, updated) – Final Guidance 14 Mar 2017
Special Interest Manual of Policies & Procedures (CDER) Date Posted
Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health 06 Mar 2017
Upcoming Meetings (* = New)
* May 17, 2017: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* May 17, 2017: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* May 24, 2017: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
* May 25, 2017: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
2017 Advisory Committee Tentative Meetings

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