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Comments Sought on Info in Dispute Resolution Guidance

06/02/2015

Federal Register Notice: FDA is seeking public comment on the information collection contained in the “Guidance for Industry...

OMB OKs Info in Prescription Drug Marketing Act

06/02/2015

Federal Register Notice: FDA’s collection of information entitled “Prescription Drug Marketing Act of 1987; Policies, ...

Comments Sought on Generic Drug User Fee Cover Sheet

06/02/2015

Federal Register Notice: FDA seeks comments on the collection of information using Form FDA 3794 entitled “Generic Drug User...

FDA to Provide Hearing Opportunity on Device Ban

06/02/2015

Federal Register Final rule: FDA is amending its regulations to clarify that it will provide an opportunity for an informal hearin...

Info on MedWatch Sent to OMB

06/01/2015

Federal Register Notice: FDA’s proposed collection of information entitled “MedWatch: The FDA Medical Products Reporti...

OMB OKs Info on Blood CGMPs/Donor Testing

06/01/2015

Federal Register Notice: FDA’s collection of information entitled, “Current Good Manufacturing Practices for Blood and...

ICH Guidance on Veterinary Drug Residues in Human Food

06/01/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Studies to Evaluate the Safety of Residues...

Guidance on Drug/Biologic Reportable CMC Changes

06/01/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Established Conditions: Reportable CMC Cha...

Patient-Focused Meeting on Alpha-1 Antitrypsin Deficiency

06/01/2015

Federal Register Notice: FDA will hold a public meeting 9/29 on Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficienc...

Rectal Control System into Class 2

06/01/2015

Federal Register Final order: FDA is classifying the rectal control system into Class 2 (special controls). The special controls a...