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Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices – Draft Guidance 31 Aug 2017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Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry – Draft Guidance 18 Aug 2017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CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports – Draft Guidance 08 Aug 2017
Child-Resistant Packaging Statements in Drug Product Labeling – Draft Guidance 02 Aug 2017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
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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

 

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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

 

 

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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”

Posted in Cato Research, Drug Development, FDA, Regulatory Affairs, Uncategorized | Tagged , , , , | Comments Off on FDA Updates ICH E14 Q&A Modelling in QTc Prolongation Studies

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
Posted in Cato Research, FDA, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , | Comments Off on New FDA Guidances for June 2017