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Aeterna Zentaris Plans FDA Meeting on AGHD Test

[ Price : $8.95]

Aeterna Zentaris says positive Phase 3 trial results for its oral diagnostic test for adult growth hormone deficiency will be revi...

FDA Does Not Approve Migraine Patch

[ Price : $8.95]

FDA sends NuPathe a complete response letter on an NDA for Zelrix (sumatriptan), a transdermal patch for treating migraine headach...

FDA Finds CGMP Problems at Nanjing Biotech

[ Price : $8.95]

FDA warns Nanjing Biotech of CGMP problems at its China drug manufacturing facility.

FDA Accepts sNDA for Relsitor

[ Price : $8.95]

FDA accepts for review a Progenics Pharmaceuticals supplemental NDA for Relistor (methylnaltrexone bromide) Subcutaneous Injection...

Woman Convicted of Unlawful Stem Cell Sales

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The Justice Department says an Arizona woman pleaded guilty to unlawful distribution of stem cells in interstate commerce.

IVD Group Says FDA Guidance Too Restrictive

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The Association for Molecular Pathology says a recent FDA draft guidance on in vitro diagnostic (IVD) tests could result in reduce...

Error Corrected in Proposal for Cardiovascular Electrodes

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Federal Register Proposed rule correction: FDA corrects an Internet address in an 8/8 Federal Register proposed rule requiring a P...

Opana ER Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Opana ER 7.5 mg and 15 mg were not withdrawn from sale for reasons of safety or effec...

Talwin Compound Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Talwin Compound tablets 325 mg were not withdrawn from sale for reasons of safety or ...

FDA Raises Concerns with Industry MDUFA 3 Proposal

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FDA raises issues about an industry performance proposal as part of MDUFA 3 reauthorization talks.