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FDA Denies Vanda Petition to Delay Generic Fanapt

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FDA denies a Vanda petition asking that it not approve an ANDA for Fanapt until expiration of a three-year exclusivity relating to...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Dongying Tiandong Pharmaceutical Co. and STI Pharma.

FDA Approves Lupins Generic Nuvigil

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FDA approves a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg generic versions of Cephalons Nuvigil, in...

FDA Priority Review for EMD Seronos Avelumab

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FDA accepts for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma.

Trump Taps Rep. Price as HHS Nominee

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President-elect Donald Trump selects House Budget Committee chair Tom Price (R-GA) to serve as HHS secretary in the next administr...

FDA, Apple Met Many Times in Last 3 Years

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E-mails obtained through the Freedom of Information Act by MobiHealthNews show a lengthy relationship between FDA and Apple on a n...

CGMP Violations at Chinas Dongying Tiandong

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FDA warns Chinas Dongying Tiandong Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients...

PADE Reporting Violations at STI Pharma

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FDAs Philadelphia District Office warns STI Pharma about postmarketing adverse drug experience reporting violations involving two ...

Industry Improves Drug Postmarketing Requirements Reporting

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The latest FDA report on the status of drug postmarketing requirements and commitments shows that industry has improved its (on-ti...

Untitled Letter to Dr. PRP America Over Unapproved Device

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CBER sends San Diego-based Dr. PRP America an untitled letter over the unapproved marketing of its medical device Dr. PRP Kit for ...