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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...

FDA Gets Injunction Against Philips Defibrillators

[ Price : $8.95]

A Massachusetts federal judge signs a consent decree barring Philips North America from manufacturing automatic external defibrill...

Draft ICH Guidance on Drug Trial Statistical Principles

[ Price : $8.95]

Federal Register notice: FDA makes available an International Council for Harmonization draft guidance entitled E9 (R1) Statistica...

Workshop on Opioid Packaging/Storgage/Disposal

[ Price : $8.95]

Federal Register notice: FDA announces a 12/11-12 public workshop on Packaging, Storage, and Disposal Options To Enhance Opioid Sa...

FDA Denies PEG 3350 Selenium Petition

[ Price : $8.95]

FDA denies an Empire State Consumer Project petition asking that it test PEG 3350 products for selenium and recall any such produc...

FDA Denies PMRS Requested Stay of Roxybond Approval

[ Price : $8.95]

FDA denies a Pharmaceutical Manufacturing Research Services petition seeking a stay in the effective date of agency approval of In...

Comments Sought on Adverse Event Reporting During Pandemic

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Federal Register notice: FDA seeks comments on an information collection extension on the Guidance for Industry on Postmarketing A...

4 Warning Letters Sent to Marijuana-derived Product Marketers

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FDA sends Warning Letters to four companies that marketed marijuana-derived products as cancer treatments.

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

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