Jan 06 2014

New FDA Guidances for December 2013

Special Interest Guidances/Information

Date Posted

Guideline for Industry and Food and Drug Administration Staff – Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate

30 Dec 2013

Naming of Drug Products Containing Salt Drug Substances (PDF – 161KB)

24 Dec 2013

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF – 75KB)

09 Dec 2013

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (PDF – 128KB)

04 Dec 2013

Other Interesting Information

MAPP Update: NDAs and BLAs: Filing Review Issues (PDF – 76KB)

17 Dec

Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings (PDF – 129KB)

04 Dec

Change in Duty Station (PDF – 181KB)

03 Dec

Good Review Practice: Clinical Review of Investigational New Drug Applications (PDF – 46KB)

02 Dec

Upcoming Meetings (* = New)

Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases; 08 Jan 2014; Silver Spring, MD
Complex Issues in Developing Drug and Biological Products for Rare Diseases; 6-7 January, 2014; Silver Spring, MD
Nanomaterial Drug Products: Current Experience and Management of Potential Risks; 14-15 Jan, 2014, Rockville, MD
Over-the-Counter Ophthalmic Drug Products – Emergency Use Eyewash Products; Announcement of Public Hearing; Request for Comments; 07 Mar 2013; Silver Spring, MD.