Revised Draft Guidance for Industry: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, February 9, 2015, Federal Register. Comments due May 11, 2015. (this document supersedes now-withdrawn Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements, 69 FR 6308 (February 10, 2004)).
Draft Guidance for Industry: Individual Patient Expanded Access Applications: Form FDA 3926, February 6, 2015, Federal Register. Comments due April 7, 2015.
Draft Guidance for Industry and FDA Staff: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally Infected Nails, January 27, 2015, Federal Register. Comments due April 27, 2015.
Draft Guidance for Industry and FDA Staff: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices, February 11, 2015, Federal Register. Comments due May 12, 2015.
Guidance for Industry and FDA Staff: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices, February 9, 2015, Federal Register.
Guidance for Industry and FDA Staff: Mobile Medical Applications, February 9, 2015, Federal Register (updated, original issued September 25, 2013).
Guidance for Industry: S10 Photosafety Evaluation of Pharmaceuticals, January 27, 2015, Federal Register.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
