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FDA Shakeup: Galson Leaves, Woodcock Back to CDER

09/24/2007

As if to help clear the decks at CDER, whose drug-safety flounderings more than anything else provoked passage of the Democrat-dri...

FDA Corrects Error in Blood Products Rule

09/24/2007

Federal Register Proposed rule and direct final rule: FDA is correcting a typographical error in the codified section of a propose...

OMB OKs Info on Pharma Development Study

09/21/2007

Federal Register Notice: FDA’s collection of information, “Pharmaceutical Development Study” has been approved b...

Comments Sought on Radioactive Drugs Regs

09/21/2007

Public Meeting on IT Resources in Reviewing NDAs

09/21/2007

Federal Register Notice: FDA solicits comments on the information collection contained in regulations governing the use of radioac...

Trial Lawyers Win ‘Anti-preemption’ Language in FDA Bill

09/21/2007

Democrats buoyed by support from trial lawyers were successful in inserting anti-preemption language in the compromise FDA Amendme...

FDA Seeks to Boost Consumer Ad Comprehension

09/21/2007

Although the pharmaceutical industry routinely employs some of the most creative and sophisticated talent available in the field o...

Info on PMA Approval Sent to OMB

09/17/2007

Federal Register Notice: FDA has submitted a proposed collection of information, “Premarket Approval of Medical Devices &mda...

Comments Reopened on IVD Assay Guidance

09/17/2007

Federal Register Notice: FDA is reopening until 10/17, the comment period for Draft Guidance for Industry, Clinical Laboratories, ...

Guidance on Commercial Analyte Specific Reagents

09/14/2007

Federal Register Notice: FDA is making available a guidance, Commercially Distributed Analyte Specific Reagents (ASRs): Frequently...