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Nov 06

New FDA Guidances for October 2018

By Joanne McNelis, Ph.D., RAC (US), Clinical Strategy Scientist II at Cato Research

FDA draft and final guidances released from CDER, CBER, and CDRH in October are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Considerations for the Development of Dried Plasma Products Intended for Transfusion – Draft Guidance 30 Oct 2018
M9 Biopharmaceutics Classification System-Based Biowaivers – Draft Guidance 25 Oct 2018
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry – Draft Guidance 25 Oct 2018
Testicular Toxicity: Evaluation During Drug Development Guidance for Industry – Final Guidance 24 Oct 2018
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Draft Guidance 18 Oct 2018
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry – Draft Guidance 16 Oct 2018
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry – Draft Guidance 15 Oct 2018
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry – Draft Guidance 15 Oct 2018
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry – Final Guidance 15 Oct 2018
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry – Revised Draft Guidance 09 Oct 2018
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry – Draft Guidance 09 Oct 2018
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act – Draft Guidance (revised final) 02 Oct 2018
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use – Final Guidance 02 Oct 2018
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs – Final Guidance 02 Oct 2018
Upcoming Meetings (* = New)  
* November 8, 2018: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* November 14, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
  November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement
* November 15, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
* December 4-5, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* December 4-5, 2018: Science Advisory Board to NCTR Meeting Announcement
* December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Last updated: 05 November 2018