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Mar 02 2015

New FDA Guidances for February 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 February 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.

Special Interest Guidances/Information Date Posted
Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Action Letters – MAPP (CDER) 26 Feb 2015
Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies – MAPP (CDER) 25 Feb 2015
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271– Draft Guidance 19 Feb 2015
Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 13 Feb 2015
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities – Draft Guidance 13 Feb 2015
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Draft Guidance 13 Feb 2015
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Draft Guidance 13 Feb 2015
Complicated Urinary Tract Infections: Developing Drugs for Treatment – Final Guidance 13 Feb 2015
Alcoholism: Developing Drugs for Treatment – Draft Guidance 11 Feb 2015
Complicated Intra-Abdominal Infections: Developing Drugs for Treatment – Final Guidance 09 Feb 2015
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs – Draft Guidance 06 Feb 2015
Individual Patient Expanded Access Applications: Form FDA 3926 – Draft Guidance 04 Feb 2015
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices – Draft Guidance 25 Feb 2015
Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices – Draft Guidance 11 Feb 2015
Upcoming Meetings (* = New)
  Vaccines and Related Biological Products Advisory Committee Meeting; 04 Mar 2015; Silver Spring, MD
  Science Board to the FDA Meeting; 04 Mar 2015; Silver Spring, MD
  Dermatologic and Ophthalmic Drugs Advisory Committee Meeting; 9 Mar 2015; Silver Spring, MD
* Anesthetic and Analgesic Drug Products Advisory Committee Meeting; 18 Mar 2015; Gaithersburg, MD
* Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting; 19 Mar 2015; Gaithersburg, MD
* Neurological Devices Panel of the Medical Devices Advisory Committee Meeting; 17 Apr 2015; Silver Spring, MD
* April 29, 2015: Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee Meeting Announcement; 29 Apr 2015; Silver Spring, MD

* new entry
Last updated: 1 March 2015