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Stakeholder Suggestions to Improve Gene Therapy Draft Guidance

[ Price : $8.95]

Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene ther...

CGMP Violations at Fresenius Ogden, UT, Plant

[ Price : $8.95]

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.

CGMP Violations Seen at Indias Reliance Life Sciences

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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

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FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, a...

IDEAYA Plans Phase 3 Study in Lung Cancer After FDA Meeting

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IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extens...

Karyopharm sNDA Filed for Xpovio in Myelofibrosis

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Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitin...