«

»

Feb 20

New FDA Guidances for January 2018

By Sheila Plant, PhD, MHS, RAC (US), Assistant Director, Regulatory Strategy, US, Cato Research

 

FDA draft and final guidances released from CDER, CBER, and CDRH in January 2018 are posted.  CDRH has also released an “A-list” and a “B-list” of proposed guidances for fiscal year 2018 and is seeking feedback on the relative priority of guidance documents.  CDRH is also intending to conduct a focused retrospective review of guidances released in 2008, 1998, 1988, and 1978.  More information can be found here:   https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm580172.htm

In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Qualified Infectious Disease Product Designation Questions and Answers 29 Jan 2018
Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry – Draft Guidance 25 Jan 2018
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) – Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 19 Jan 2018
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry – Final Guidance 18 Jan 2018
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry – Draft Guidance 18 Jan 2018
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff  – Final Guidance 16 Jan 2018
Good ANDA Submission Practices Guidance for Industry – Draft Guidance 03 Jan 2018
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry – Draft Guidance 02 Jan 2018
Upcoming Meetings (* = New)
March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee
* March 8, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement
* March 22, 2018: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
* March 23, 2018: Pediatric Advisory Committee Meeting Announcement
Last updated: 15 February 2018