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Novartis sBLA for Kymriah in Lymphoma Patients

[ Price : $8.95]

Novartis files a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients w...

Comments Sought on Drug Safety Reporting Extension

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension on Postmarketing Safety Reports for Human Drug ...

Guidance on Device Patient Data Sharing

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Manufacturers Sharing Patient-Specific Information from Medical D...

Multiple Violations in Kim Chemicals Inspection

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FDA warns Indias Kim Chemicals about CGMP and other violations in its manufacturing of OTC products.

Safety Concern Continues with Abbotts Absorb Scaffold: FDA

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An FDA safety update says that interim study results from a pivotal clinical trial continue to show an increased rate of major adv...

CGMP Violations at Accelerated Analytical Labs

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FDA warns Accelerated Analytical Laboratories about CGMP violations at its drug manufacturing facility.

FDA Recognizes Drug Inspections by 8 European Countries

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FDA says it will recognize drug manufacturing inspections from eight European countries, avoiding duplication of inspections and r...

Accelerated Approval for AstraZenecas Calquence

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As a condition of approval, FDA is requiring that AstraZeneca conduct additional studies to verify and describe anticipated clinic...

FDA Encouraging Device Security Updates

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CDRH associate director Suzanne Schwartz says the agency works with medical device manufacturers to address cybersecurity issues.

NJ Proposes Limits on Payments, Gifts to Prescribers

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Attorney Serra Schlanger says New Jersey is considering a proposal to restrict drug company payments and gifts to healthcare profe...