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Trump Said to Modernize, Improve Flu Vaccines

[ Price : $8.95]

The White House says President Trump has signed an executive order intended to modernize flu vaccines and help protect more Americ...

NDA to BLA List Updated

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FDA updates its preliminary list of approved NDAs that will be considered BLAs as of 3/23/20.

Guide on Drug Distributor Verification Requirement

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Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable...

Comments Sought on Pediatric Drug Safety Reviews

[ Price : $8.95]

Federal Register notice: FDA seeks comments related to post-marketing pediatric-focused safety reviews of products posted between ...

Panel to Review Makena Unfavorable Study

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Federal Register notice: FDA announces a 10/29 advisory committee meeting to review an Amag Pharma confirmatory clinical trial tha...

MAPP on Patient-Oriented Labeling Consults

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CDER issues a MAPP with procedures to be followed when its Division of Medication Error Prevention consults its Division of Medica...

Dietary Supplement CGMP Violations at Nutra Solutions

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FDA warns Nutra Solutions about CGMP violations in its work as a contract manufacturer of dietary supplements.

FTC Questions Ads for Drug Company Lawsuits

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FTC warns seven unidentified legal practitioners and lead generators that TV ads soliciting clients to sue drug companies may be d...

AveXis Fires 2 Execs for Data Manipulation

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AveXis tells FDA it has terminated two senior executives who were the subject of a company investigation into data manipulation fo...

FDA OKs Cardiovascular Systems ViperWire

[ Price : $8.95]

FDA approves a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip.