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Guidance on Biosimilar Sponsor Formal Meetings

11/18/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Formal Meetings Between the FDA and Biosimilar B...

FDA Posts Approved PMAs

11/18/2015

Federal Register Notice: FDA is publishing a list of PMAs that have been approved and is informing the public of the availability ...

Guidance on Labeling for Drugs Containing Acetaminophen

11/17/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Organ-Specific Warnings: Internal Analgesic, Ant...

Alexion Pharma Receives Voucher for Strensiq

11/17/2015

Federal Register Notice: FDA is issuing a priority review voucher to the sponsor of a rare pediatric disease product application, ...

OMB OKs Info on MedWatch

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “MedWatch: The Food and Drug Administration Medical ...

OMB OKs Info On Device Labeling Regs

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “Medical Device Labeling Regulations” has been...

Comments Sought on IVD Device Studies Guidance

10/23/2015

Federal Register Notice: FDA is seeking public comments on guidance on informed consent for in vitro diagnostic device studies usi...

OMB OKs Info on Device Recall

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “Medical Device Recall Authority” has been app...

Guidance on Package Types for Injectable Products

10/22/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Selection of the Appropriate Package Type ...

OMB OKs Info on Formal Evidentiary Hearing

10/21/2015

Federal Register Notice: FDA’s collection of information entitled “Administrative Practices and Procedures; Formal Evi...