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Guidance on OTC Pediatric Acetaminophen Liquid Drugs

08/05/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Over-the-Counter Pediatric Oral Liquid Drug Prod...

Tissue Marker into Class 2

08/05/2015

Federal Register Final order: FDA is classifying the internal tissue marker into Class 2 (special controls). The special controls ...

Guidance on Stability Testing for New Veterinary Drugs

07/31/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Bracketing and Matrixing Designs for Stability T...

Comments Re-opened on Modified Risk Tobacco Products

07/31/2015

Federal Register Notice: FDA is reopening the period until 8/31 for public comment on modified risk tobacco product applications (...

Info on Tobacco Data Sent to OMB

07/27/2015

Federal Register Notice: FDA’s collection of information entitled, “Generic Clearance for the Collection of Qualitativ...

Guidance on Analytical Procedures/Methods Validation

07/27/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Analytical Procedures and Methods Validation for...

Guidance on Nonprescription Drug AERs

06/25/2015

Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry on Postmarketing Adverse Eve...

Comments Sought on Hearing DTC Ads

06/25/2015

Federal Register Notice: FDA is seeking public comment on research entitled “Hearing, Aging, and Direct-to-Consumer Televisi...

Guidance on Injectable Drug/Biologic Excess Volume

06/25/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Allowable Excess Volume and Labeled Vial Fill Si...

FDA Corrects Notice on Outsourcing Facility Bulk Drug List

06/25/2015

Federal Register Notice: FDA is correcting a notice entitled “List of Bulk Drug Substances That May Be Used by an Outsourcin...