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FDA Guidance on Patient Counseling Info Section in Drug Labels

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FDA posts a final guidance on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Produc...

Judge Allows Generic Cubicin in 2016

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A Delaware federal district judge says Hospira can sell a generic form of Cubists Cubicin after one upheld patent expires in 2016....

FDA Asked to Pull Laboratory-developed Test Guidance

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Some 51 organizations ask FDA to withdraw its proposed guidance on laboratory-developed tests and proceed through notice and comme...

Blog Urges Learned Intermediary Exception for DTC

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Harvard Law student Zachary Shapiro says states should consider approving a DTC exception to the learned intermediary rule to forc...

FDA Clears 510(k) for Focus Diagnostics Simplexa Flu Test

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FDA clears a Focus Diagnostics 510(k) for the Simplexa Flu A/B & RSV Direct Kit for testing for eight additional influenza strains...

FDA Urging UDI Adoption

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CDRH director Jeffrey Shuren calls on many stakeholders to adopt the medical device unique device identifier as a means of improvi...

FDA Corrects Notice on Tobacco Data Collection

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Federal Register Notice: FDA corrects an incorrect docket number in an 8/1 notice on the generic clearance for the collection of q...

Guidance on Pharmacology for Drug/Biologic Pediatric Studies

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Federal Register Notice: FDA releases a draft guidance: General Clinical Pharmacology Considerations for Pediatric Studies for Dru...

Comments Extended on CMC Guidance

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Federal Register Notice: FDA extends the comment period for a draft guidance on two-phased chemistry, manufacturing, and controls ...

Guidance on Bacterial Testing of Platelets

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Federal Register Notice: FDA releases a draft guidance: Bacterial Detection Testing by Blood Collection Establishments and Transfu...