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Alert on Cook Medical Sizing Catheters

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical.

Rep. Auchincloss Seeks FDA Whistleblowers

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Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency mana...

Telix NDA Resubmission for Brain Cancer Imaging Agent

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FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.

FDA Cites Manufacturing, Quality Lapses at Orchid Pharma

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FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by O...

Will the Push for DTC Pre-Review Grow?

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Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-revie...

RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

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HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the T...

Alymsys Patient Brochure False or Misleading: FDA

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The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misl...

America First Fee Incentives Discussed in PDUFA Meeting

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Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee i...

Granules Steps Up Oversight at Troubled India Facility

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Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance i...

Inspection Cites Thermo Fisher Manufacturing Facility

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FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.