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Dec 01 2015

New FDA Guidances for November 2015

By Brant Hamel, Ph.D., Regulatory Scientist at Cato Research
FDA draft and final guidances, released from CDER, CBER, and CDRH in November 2015, are posted.  In addition, upcoming advisory committee meetings to be held are also listed below with a link to more information.

Special Interest Guidances/Information Date Posted
Certification Process of Designated Medical Gases – Draft Guidance 24-Nov-2015
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process – Draft Guidance 20-Nov-2015
Over-the-Counter Sunscreens: Safety and Effectiveness Data Guidance for Industry – Draft Guidance 20-Nov-2015
Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry – Draft Guidance 20-Nov-2015
Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act – Draft Guidance 20-Nov-2015
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants – Draft Guidance 17-Nov-2015
Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection – Draft Guideline for Industry and Food and Drug Administration Staff – Draft Guidance 17-Nov-2015
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — – Final Guidance 16-Nov-2015
Minutes of Institutional Review Board (IRB) Meetings – Draft Guidance for Institutions and IRBs – Draft Guidance 5-Nov-2015
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 2-Nov-2015
Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment – Final Guidance 2-Nov-2015
Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens – Guideline for Industry and Food and Drug Administration Staff – Draft Guidance 2-Nov-2015
Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff – Draft Guidance 30-Oct-2015
Upcoming Meetings (* = New)
Psychopharmacologic Drugs Advisory Committee, 01 December 2015; Silver Spring, MD
Pulmonary-Allergy Drugs Advisory Committee, 09 December 2015; Silver Spring, MD
Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and the Risk Management Advisory Committee, 10 December 2015; Silver Spring, MD
* Endocrinologic and Metabolic Drugs Advisory Committee , 14 December; Silver Spring MD
* Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, 19 February; Gaithersburg, MD
* new entry
Last updated: 30 November 2015