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Guidance on Dietary Supplement Labeling

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on the labeling of dietary supplements as required by the Dietary Supplement and ...

Review Period Set for Tapentadol HCl

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Grunenthal GmbHs tapentadol hydrochloride for the purpose...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Byrne Medical, Galderma Laboratories, and Gaven Medical.

FDA Accepts J&J Response on Antibiotic NDA

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FDA accepts a Johnson & Johnson Pharmaceutical Research & Developments response to a 11/08 complete response letter on an NDA for ...

Advisors Call for Clolar Trial

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FDAs Oncologic Drugs Advisory Committee votes 9-3 to recommend that Genzyme be required to conduct a randomized controlled trial o...

Risk Promotion Guidance Needs More Specificity: CHC

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The Coalition or Healthcare Communication says that FDAs draft guidance on presenting risk information in promotional materials is...

FDA Grants Orphan Status for Delcath Liver Cancer Drug

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FDA grants orphan drug status for Delcath Systems use of doxorubicin with its percutaneous hepatic perfusion technology for treati...

FDA OKs Watsons Generic Plan B

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FDA approves a Watson Laboratories ANDA for Next Choice (levonorgestrel tablets 0.75 mg), a generic copy of Duramed Pharmaceutical...

Awaiting FDA, Genzyme Inspected by EMEA

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The European Medicines Agency (EMEA) concludes an inspection at Genzymes troubled Allston Landing, MA manufacturing plant, while t...

FDA Update on Erythromycin Ophthalmic Ointment Shortage

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FDA says Bausch & Lomb is ramping up production to meeting increased demand for erythromycin ophthalmic ointment in its 50 x 1gm p...