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Info on Medicated Articles CGMPs Sent to OMB

06/20/2014

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations fo...

Guidance on Gene Therapies, Vectored Vaccines

06/20/2014

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Determining the Need for and Con...

Comments Sought on GLP Regs for Nonclinical Studies

06/12/2014

Review Period Set for AZ’s Vandetanib

06/11/2014

Federal Register Notice: FDA has determined the regulatory review period for AstraZeneca’s Vandetanib is 4,009 days for exte...

Drug Supply Chain Security Guidance

06/11/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Drug Supply Chain Security Act Implementat...

Guidance on Global Unique Device ID Database

06/11/2014

Federal Register Notice: FDA is making available a guidance entitled Global Unique Device Identification Database (GUDID): Guidanc...

Guidance on Distributing Risk Info on Approved Products

06/11/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Distributing Scientific and Medical Public...

Info on Tobacco Product Equivalence Sent to OMB

06/10/2014

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry and Food and Drug Administra...

Comments Sought on Humanitarian Use Device Info

06/10/2014

Federal Register Notice: FDA is seeking comments on information collection requirements for humanitarian use devices (HUDs). Comme...

Review Period Set for Stendra

06/10/2014

Federal Register Notice: FDA has determined the regulatory review period for Mitsubishi Tanabe Pharma Corp.’s Stendra (avana...