New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be held in July is also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings – Draft Guidance 30 Jun 2015
DSCSA Implementation: Product Tracing Requirements for Dispensers - Final Guidance 30 Jun 2015
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance 29 Jun 2015
Unique Device Identification: Direct Marking of Devices – Draft Guidance 26 Jun 2015
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products- Final Guidance 24 Jun 2015
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules- Final Guidance 18 Jun 2015
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions- Draft Guidance 18 Jun 2015
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Final Guidance 17 Jun 2015
Naming of Drug Products Containing Salt Drug Substances – Final Guidance 16 Jun 2015
Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry – Draft Guidance 11 Jun 2015
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide) – Final Guidance 10 Jun 2015
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 9 Jun 2015
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products – Final Guidance 9 Jun 2015
Upcoming Meetings (* = New)
* Oncologic Drugs Advisory Committee Meeting, 09 July 2015; Silver Spring, MD

* new entry
Last updated: 01 July 2015

Posted in Cato Research, Clinical Trials, Drug Development, eCTD, Medical Research, Regulatory Strategy, Regulatory Submissions | Tagged , , , , , , , | Leave a comment

Credentialing Developments at Cato Research

In 2014, approximately 20-25 members of the global CATO staff participated in extensive training sessions devoted to Canadian Regulatory Affairs. This effort was led by Amelie Rodrigue-Way, PhD from the Montreal office of CATO Research Ltd.

During the last 8 months, one of the tangible and visible results of this training has been the successful completion of the Canadian Regulatory Affairs Certification Examination by two members of the global Cato Research staff:  Dr. Amelie Rodrigue-Way (of CATO’s Montreal office) and Dr. Jack Snyder (of CATO’s Washington office).

Fewer than 500 individuals worldwide have achieved the designation of Certified in Canadian Regulatory Affairs, a credential sponsored by the Regulatory Affairs Professional Society (Rockville, MD).

This achievement speaks to the continuing effort at CATO to acquire and maintain up-to-date regulatory knowledge, experience, and credentials relevant to global biomedical product developmental activities.

Posted in Canadian Regulatory Affairs, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , | Leave a comment

New FDA Guidances for May 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in May, are posted. In addition, upcoming advisory committee meetings and other public meetings hosted by FDA are listed below with links to more information.

Also, as we strive to keep you updated on the latest FDA guidances, please note that FDA has officially withdrawn 47 draft guidances.  All guidances were published prior to 31 December 2013 but were never finalized.  The full list of withdrawn guidances, published in the Federal Register on 06 May 2015, can be found here:  http://www.gpo.gov/fdsys/pkg/FR-2015-05-06/html/2015-10477.htm.

Special Interest Guidances/Information Date Posted
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry – Draft Guidance 29 May 2015
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - Final Guidance 27 May 2015
Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures – Final Guidance 27 May 2015
ANDA Submissions — Refuse-to-Receive Standards – Final Guidance 26 May 2015
Adaptive Designs for Medical Device Clinical Studies - Draft Guidance 18 May 2015
Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling- Draft Guidance 18 May 2015
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators- Draft Guidance 14 May 2015
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment - Draft Guidance 12 May 2015
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 – Draft Guidance 12 May 2015
Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Draft Guidance 12 May 2015
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices – Draft Guidance 06 May 2015
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Revision 3; Draft Guidance 05 May 2015
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System – Revision 1, Draft Guidance 05 May 2015
Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States – Draft Guidance 22 Apr 2015
Upcoming Meetings (* = New)
Transmissible Spongiform Encephalopathies Advisory Committee Meeting; 01 June 2015; Silver Spring, MD
* Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting; 04 June 2015; Silver Spring, MD
* Risk Communication Advisory Committee Meeting; 08-09 June 2015; Silver Spring, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 09 June 2015; Gaithersburg, MD
Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 10 June 2015; Gaithersburg, MD
* June 11, 2015: Pulmonary-Allergy Drugs Advisory Committee Meeting; 11 June 2015; Gaithersburg, MD

* new entry

Last updated: 01 June 2015

Posted in Cato Research, Clinical Trials, Drug Development, FDA | Tagged , , , , , , , | Comments Off

New FDA Guidances for April 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in April 2015, are posted.  In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information. 

Special Interest Guidances/Information Date Posted
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry – Final Guidance 28 Apr 2015
Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product – Final Guidance 28 Apr 2015
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product -  Final Guidance 28 Apr 2015
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity - Draft Guidance 28 Apr 2015
M8 Electronic Common Technical Document (eCTD) v4.0 DRAFT Implementation Guide v2.0; and eCTD Implementation Package DRAFT Specification for Submission Formats v2.0 – Draft Guidance 22 Apr 2015
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs - Draft Guidance 21 Apr 2015
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions  - Final Guidance 13 Apr 2015
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval – Final Guidance 13 Apr 2015
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry (PDF – 635KB) – Draft Guidance 06 Apr 2015
Abuse-Deterrent Opioids-Evaluation and Labeling – Final Guidance 01 Apr 2015
Procedures for Meetings of the Medical Devices Advisory Committee – Draft Guidance 01 Apr 2015
Upcoming Meetings (* = New)
Pulmonary-Allergy Drugs Advisory Committee Meeting; 12 May 2015; Gaithersburg, MD
Vaccines and Related Biological Products Advisory Committee Meeting; 12 May 2015; Silver Spring, MD
Blood Products Advisory Committee Meeting; 13 May 2015; Silver Spring, MD
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting; 14-15 May 2015; Silver Spring, MD
* Transmissible Spongiform Encephalopathies Advisory Committee Meeting Announcement; 01 June 2015; Silver Spring, MD
* Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement; 09 June 2015; Gaithersburg, MD
* Endocrinologic and Metabolic Drugs Advisory Committee Meeting; 10 June 2015; Gaithersburg, MD

* new entry

Last updated: 6 May 2015

Posted in Cato Research, Clinical Trials, Drug Development, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , , , , , | Comments Off

New FDA Guidances for March 2015

By Sheila R. Plant, Ph.D., R.A.C., Regulatory Scientist at Cato Research

FDA draft and final guidances, released from CDER, CBER, and CDRH in March 2015, are posted.  Two updates to the CDER Manual of Policies and Procedures (MAPP) are included.  In addition, upcoming advisory committee meetings to be held in the next couple months are listed below with links to more information.

Of special interest, please note revision 2 of guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” posted on 10March2015.  With this rendition of the guidance, Type A Meeting packages would be submitted at the same time as the meeting request.  There is also clarification regarding granted meeting dates when a day is requested beyond the 30/60/75 day window; specifically FDA has indicated that the meeting should be held within 14 calendar days of the requested date.

 

Special Interest Guidances/Information Date Posted
Development and Submission of Near Infrared Analytical Procedures – Draft Guidance 30 Mar 2015
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products- Final Guidance 25 Mar 2015
Electronic Submission of Lot Distribution Reports- Final Guidance 20 Mar 2015
NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide - CDER MAPP 17 Mar 2015
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Draft Guidance 17 Mar 2015
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products – Draft Guidance 10 Mar 2015
Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited Review – CDER MAPP 09 Mar 2015
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers – Draft Guidance 06 Mar 2015
Clinical Trial Imaging Endpoint Process Standards - Draft Guidance 04 Mar 2015
Upcoming Meetings (* = New)
* Cardiovascular and Renal Drugs Advisory Committee Meeting; 15 April 2015; Silver Spring, MD
* Neurological Devices Panel of the Medical Devices Advisory Committee Meeting; 17 April 2015; Silver Spring, MD
* Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee Meeting; 29 April 2015; Silver Spring, MD
* Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee; 30 April – 01 May 2015; Gaithersburg, MD
* Pulmonary-Allergy Drugs Advisory Committee Meeting; 12 May 2015; Gaithersburg, MD
* Vaccines and Related Biological Products Advisory Committee Meeting; 12 May 2015; Silver Spring, MD
* Blood Products Advisory Committee Meeting; 13 May 2015; Silver Spring, MD
* Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting; 14-15 May 2015; Silver Spring, MD

* new entry

Last updated: 12 April 2015

Posted in Cato Research, Drug Development, FDA, Regulatory Strategy, Regulatory Submissions | Tagged , , , , , | Comments Off