Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products, March 24, 2015, Federal Register.
Guidance for Industry: Critical Path Innovation Meetings, March 31, 2015, Federal Register.
Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling, April 2, 2015, Federal Register.
Guidance for Industry: Residual Solvents in Animal Drug Products, April 3, 2015, Federal Register.
Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information, March 31, 2015, Federal Register. Comments due May 29, 2015.
Draft Guidance for Industry: Target Animal Safety Data Presentation and Statistical Analysis, March 31, 2015, Federal Register. Comments due June 1, 2015.
Draft Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures, March 31, 2015, Federal Register. Comments due June 1, 2015.
Draft Guidance for Industry and FDA Staff: Procedures for Meetings of the Medical Devices Advisory Committee, April 1, 2015, Federal Register. Comments due June 1, 2015.
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