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Info on Orphan Drug Application Forms Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on orphan drugs a...

OMB OKs Info Collection on Drug/Biologic User Fees

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on user fee waivers, reduct...

FDA Guidance on Pathological Response in Breast Cancer

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FDA posts a guidance on Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an ...

Alcobra Reports Top Line Results in ADHD Drug Trial

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Alcobra says a Phase 3 study of its Attention Deficit Hyperactivity Disorder drug metadoxine extended release showed statistically...

Sagent Pharma Recalls 3 Ketorolac Lots Due to Labeling Error

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Sagent Pharmaceuticals recalls three lots of ketorolac tromethamine injection 30mg/mL single-dose vials due to a labeling error.

Takeda Loses Actos Liability Trial in PA

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A jury rules in an Actos product liability case, Frances Wisniewski v. Takeda Pharmaceuticals North America, finding in favor of t...

FDA Inspection Report Cites Masimos Complaint Probes

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A just-released FDA Form-483 says Irvine, CA-based device maker Masimo failed to adequately investigate complaints about potential...

FDA Posts 9 Updated and 3 New MedGuides

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FDA updates its Medication Guides Web page to add nine updated and three new guides.

FDA Denies Petition Seeking Restrictions on N-methyl Pyrrolidone

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FDA rejects a citizen petition from Neurelis that asked FDA to refrain from approving any intranasal product for treating epilepsy...

Generic Drug Regulatory Science Eyes Post-market Evaluations

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CDER says generic drug post-market evaluations and complex products equivalence top the list of fiscal year 2015 regulatory scienc...