«

»

Mar 18 2019

New FDA Guidances for February 2019

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

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

 

Special Interest Guidances/Information Date Posted
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 28 Feb 2019
Quality Considerations for Continuous Manufacturing Guidance for Industry – Draft Guidance 26 Feb 2019
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations – Draft Guidance 25 Feb 2019
Bioavailability Studies Submitted in NDAs or INDs – General Considerations – Draft Guidance 25 Feb 2019
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 25 Feb 2019
Refuse to Accept Policy for 510(k)s – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 25 Feb 2019
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 25 Feb 2019
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products Guidance for Industry – Draft Guidance 21 Feb 2019
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry – Final Guidance 19 Feb 2019
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry – Final Guidance 19 Feb 2019
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Feb 2019
Competitive Generic Therapies Guidance for Industry – Draft Guidance 15 Feb 2019
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality – Draft Guidance 13 Feb 2019
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements – Guidance for Industry and Food and Drug Administration Staff – Final Guidance 08 Feb 2019
Principles of Premarket Pathways for Combination Products – Draft Guidance 06 Feb 2019
Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment – Final Guidance 06 Feb 2019
The Least Burdensome Provisions: Concept and Principles – Guidance for Industry and FDA Staff – Final Guidance 05 Feb 2019
Upcoming Meetings (* = New)
* March 19-20, 2019: Science Advisory Board to the National Center for Toxicological Research Meeting Announcement
* March 20-21, 2019: Blood Products Advisory Committee Meeting Announcement
March 21, 2019: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* March 25-26, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
Last updated: 07 March 2019