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Stakeholders make recommendations they say would improve an FDA draft guidance on remote regulatory assessments.

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...

Guide on Pediatric Study Ethical Considerations

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Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Product...

New Regulatory Paradigm Needed for Device Software: FDA

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FDA concludes after ending a recent pilot program on software as a medical device that a new regulatory paradigm is needed to regu...

3 Biocon Biologics FDA-483s Posted

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FDA posts three Form FDA-483s issued to Indias Biocon Biologics following three on-site August inspections at the companys seven m...

OGD Director Choe Leaving FDA Next Month

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CDER Office of Generic Drugs director Sally Choe decides to leave FDA effective 10/8 to pursue opportunities outside the agency.