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FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

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FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transc...

FDA cites Bausch + Lomb Manufacturing Facility

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FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility i...

Lillys Retatrutide Hits Endpoint in 2 Trials

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Lilly says its triple hormone receptor agonist retatrutide met the primary weight loss endpoint in two Phase 3 trials.

FDA Should Ban DTC Drug Ads: Public Citizen

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Advocacy group Public Citizen files a petition urging FDA to ban prescription drug direct-to-consumer advertising.

FDA Accepts Revolution Medicines' NDA for Pancreatic Cancer Therapy

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FDA accepts for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with ...

2026 Warning Letter Trends Analyzed by Attorney

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Attorney Megan Robertsons analysis of 2026 FDA Warning Letters shows that CDER has been the most active Center, going after telehe...

4 Observations in Behring German Facility Inspection

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FDA releases the form FDA-483 issued following a 2026 inspection at the CSL Behring biological drug manufacturing facility in Marb...

FDA: PDUFA 7 CMC Commitments Complete

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FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...

Efforts Needed to Improve Health Outcomes, Califf Says

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Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...

HELP Committee Advances Biosimilar Bill

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The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...