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Biologic Reporting Info Collection Extesnsion

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for biological and cell product deviation repor...

Dr. Reddys Unit 2 FDA-483

[ Price : $8.95]

FDA posts the FDA-483 issued following an inspection at the Dr. Reddys Unit 2 API manufacturing facility in Andhra Pradesh, India....

PhysIQ Respiration Rate Algorithm Cleared

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FDA clears a PhysIQ 510(k) for use of the companys algorithm to continuously determine respiration rate in ambulatory patients.

Limit Standing for Antitrust Claims: WLF

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Washington Legal Foundation and PhRMA ask the 1st Circuit Court of Appeals to limit standing to sue in antitrust cases to those wh...

Trump Working on Canada Drug Imports: Azar

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HHS secretary Alex Azar says he and President Trump are working on a plan to allow the U.S. to import drugs from Canada.

Device Use Fee FY 2020 Rates Set

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Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2020.

Revised Draft Guide on Pediatric Priority Vouchers

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Federal Register notice: FDA makes available a revised draft guidance entitled Rare Pediatric Disease Priority Review Vouchers.

FDA Clears Solios Alfa Plus for Pain

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FDA clears a Solio 510(k) for its Alfa Plus, intended for use in relieving chronic pain in addition to pain from trauma, sports in...

Scientific Solutions Global Inspection Violations

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FDA warns Scientific Solutions Global about CGMP and other violations in the production of finished drugs.

California Pay-for-Delay Settlements

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California reaches pay-for-delay settlements with four drug companies bringing $70 million to the state.