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Guidance Answers More Expanded Access Questions

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Two Arnall Golden Gregory attorneys outline highlights in a new FDA question-and-answer guidance on expanded access and suggest wa...

Cotton Asks DoJ Probe of Counterfeit Drugs

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Sen. Tom Cotton poses questions for attorney general Pam Bondi about the Justice Departments activities to stop counterfeit drugs ...

Put Restrictions on Leqvio ANDA or NDA: Petition

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Novartis asks FDA to restrict ANDAs or 505(b)(2) NDAs citing the companys Leqvio as the reference-listed drug.

TX Wins $41.5 Million in Adulterated Drug Settlement

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Texas attorney general Ken Paxton reaches a $41.5 million settlement with Pfizer and Tris Pharma after accusing the companies of p...

Ocuvex Resubmits NDA for Glaucoma Drug

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Sun Pharma Advanced Research Company says that Ocuvex Therapeutics has resubmitted an NDA for PDP-716, more than two years after t...

FDA Warns Indian API Maker Over Quality Lapses

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FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the companys acti...

Mercks Winrevair Sees Phase 2 Pulmonary Hypertension Win

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Merck reports that its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heartlung function in a mid-stage...

8 Observations on NerPharMa FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Milan, Italy-based NerPharMa drug manufacturing facility.

Revisions Sought to Draft Safety Labeling Changes Guidance

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Three stakeholders ask FDA to consider making specific revisions to its draft guidance on new safety labeling change provisions in...

Bill to Strengthen Biopharmaceutical Manufacturing

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Sens. Chris Coons and Ted Budd introduce legislation to promote improvements in U.S. biopharmaceutical manufacturing through a new...