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FDA Needs Unauthorized Test Enforcement Policy: GAO

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The Government Accountability Office says FDA should develop a policy on starting and ending enforcement discretion for unauthoriz...

6 Observations in Aurobindo Inspection

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Aurobindo reports receiving a six-item FDA 483 after an inspection at its Unit VII oral drug manufacturing unit in Jadcherla, Hyde...

QSR Proposed Revisions Will Advance Harmonization: Post

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Pharmatech Associates managing director Stephanie Gaulding discusses the effects of an FDA proposed revision to the medical device...

BMS Updates Psoriasis Drug Safety/Efficacy

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Bristol Myers Squibb provides two-year results from its POETYK PSO long-term extension trial of deucravacitinib in adult patients ...

Meeting on User Fee Financial Transparency

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Federal Register notice: FDA announces a 6/7 public meeting entitled Financial Transparency and Efficiency of the Prescription Dru...

Appeals Court Decision Hurts Drug Research Incentives: FDA

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FDA says an appeals court decision in a case involving orphan drug exclusivity is likely to slow research and innovation into drug...

Can Development Time be Cut 50% From Covid Lessons?

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CBER director Peter Marks says he wants to continue the Operation Warp Speed attention and quick approval process given to Covid-1...

Lou Gehrigs Drug Now in Oral Suspension

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FDA approves an oral suspension formulation of Mitsubishi Tanabe Pharma Americas Radicava (edaravone) for treating adults with amy...

FDA Extends PDUFA Dates for Amicus AT-GAA NDA, BLA

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FDA extends for 90 days the PDUFA review action dates for Amicus BLA and NDA for components of its AT-GAA, intended to treat late-...

Monitor Cybersecurity Regulation Developments: Attorneys

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Ropes & Gray attorneys see increasing cybersecurity expectations for medical device manufacturers in FDA regulations and congressi...