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CGMP Violations Seen at Indias Reliance Life Sciences

[ Price : $8.95]

FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.

Pharmaceutics International CGMP Violations

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FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.

2 Companies Pause Some CAR T Studies

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Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse eve...

FDA Backs PFAS Used in Medical Devices

[ Price : $8.95]

FDA adds a new frequently asked questions section to its Web page on PFAS (per- and polyfluoroalkyl substances) in medical devices...

Guidance on Pharmacokinetics in Patients with Impaired Hepatic Function

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FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, a...

CGMP Violations at Fresenius Ogden, UT, Plant

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FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.

Two Guidances on Dental Composites and Curing Lights

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FDA posts two guidance documents on dental composite resins and curing lights.

D.C. Circuit Raises Bar for Generic Drug Exclusivity

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An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after mis...

FDA, Regulatory Partners Agree on Alternative Endotoxin Test

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FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach...

Rules Needed on Complete Response Letter Transparency: Researchers

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Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.