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Aptalis Petitions FDA to Block Canasa Generics

[ Price : $8.95]

Aptalis Pharma files a citizen petition seeking to block approval of generic versions of Canasa (mesalamine) rectal suppositories,...

FDA Approves Valeant Pharma NDA for Luzu

[ Price : $8.95]

FDA approves a Valeant Pharmaceuticals NDA for Luzu (luliconazole) Cream, 1% for topical treatment of athletes foot, jock itch and...

FDA to Participate in Device Single Audit Program

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Federal Register Notice: FDA plans participation in the Medical Device Single Audit Program International Coalition Pilot Program.

Alkermes Seeks Bioquivalence Guidance Changes for Risperidone

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Alkermes asks FDA to amend its draft bioequivalence recommendations for risperidone intramuscular injection (Janssens antipsychoti...

CDER Regulatory Flexibility Lags in Quality-by-Design Initiative

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CDER Office of New Drug Quality Assessment acting director Christine Moore says that while quality-by-design principles have been ...

FDA Denies Hearing, Debars Diamond

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Federal Register Notice: FDA denies a request from Bruce I. Diamond for a hearing and is debarring him from providing services to ...

Comment Period Reopened on Medical Foods Guidance

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Federal Register Notice: FDA reopens the comment period on a draft guidance entitled Frequently Asked Questions About Medical Food...

Guidance on Device Development

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Federal Register Notice: FDA releases a draft guidance: Medical Device Development Tools.

FDA Approves Implantable Brain Stimulator for Seizures

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FDA approves a Neuropace PMA for the RNS Stimulator, a device intended to help reduce seizure frequency in epilepsy patients who h...

HHS Study Reviews Human Subject Protections at Biobanks

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A new HHS study recommends that the Office for Human Research Protections provide a forum to IRBs and principal investigators for ...