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Generic Drug Safety Labeling Legislation

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Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information ...

Pediatric Extrapolation is Expanding: Study

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FDA researchers say the use of pediatric extrapolation since 2015 has expanded and been refined.

Clean User Fee Bill Added to Continuing Resolution

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House and Senate negotiators agree to terms to reauthorize the agencys user fee programs under a clean absent any policy/program ...

Warning Issued to German OTC Drug Maker Over GMPs

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FDA sends a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische af...

Two Proposed Rules Modify Certain IRB Oversight

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Federal Register proposed rules: FDA issues two proposed rules that modify certain research requirements regarding approval/oversi...

Biogen Pays $900 Million in Whistleblower Suit

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Biogen pays $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to...

Comments on Remote Assessment Guidance

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Stakeholders make recommendations they say would improve an FDA draft guidance on remote regulatory assessments.

Comments on Fit-For-Purpose Draft Guidance

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Five stakeholders raise substantive concerns about an FDA draft guidance on selecting, developing, or modifying fit-for-purpose cl...

Reporters Urged to Probe FDA Transparency

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The Association of Health Care Journalists urges its journalist members to look deeper into FDAs use of advisory committees in its...

Calcium Carbonate OK for Use in Supplements

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Federal Register final rule: FDA amends the color additive regulations to allow calcium carbonates use in dietary supplement table...