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Bioequivalence Recommendations for Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Dabigatran Etexilate Mesylate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Aspirin; Omeprazole– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Tenofovir Alafenamide Fumarate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Uridine Triacetate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Obeticholic Acid– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Dorzolamide Hydrochloride– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Brimonidine Tartrate– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Fluphenazine Hydrochloride– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Glycopyrrolate Inhalation Powder– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Aspirin– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Diclofenac Sodium– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Brivaracetam– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Silver Sulfadiazine– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Triamcinolone Acetonide (ointment)– Draft Guidance 11 July 2017
Bioequivalence Recommendations for Cyanocobalamin– Draft Guidance 11 July 2017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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