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Spanberger Wants More ADHD Drug Info

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Rep. Abigail Spanberger asks FDA and DEA for additional information on their efforts to address shortages of ADHD drugs.

Boehringer Ingelheim Inspection Report Posted

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FDA posts the establishment inspection report with seven observations from a 2023 inspection at a Boehringer Ingelheim drug manufa...

FDA Removes Imaging Ban on FreeStyle Libre

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FDA approves the removal of an imaging contraindication on Abbotts FreeStyle Libre 2 and 3 continuous glucose monitoring systems.

More ANDA Product-Specific Guidances

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Federal Register notice: FDA makes available additional revised draft product-specific guidances that provide recommendations on b...

Advisors Asked About Lexicons Sotagliflozin

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FDA raises questions to be considered at a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting discussing a Lexico...

FDA, VA to Test Health AI Tools

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FDA and the Veterans Administration say they are partnering to open a virtual laboratory to evaluate health-related artificial int...

PTC Therapeutics NDA Resubmission for Duchenne Drug

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FDA accepts for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duc...

Fast Track Status for Prolong Stroke Drug

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FDA grants Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treat...

CGMP Violations at Turkeys MedOffice Saglik

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FDA warns Turkeys MedOffice Saglik Endustri Anonim Sirketi about CGMP violations in its manufacturing of finished drugs.

8 Observations in Novo Nordisk FDA-483

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FDA releases a form FDA-483 with eight observations from an inspection at a Novo Nordisk drug substance manufacturing facility in ...