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FDA OKs Orion sNADA for Cats

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Online Report Hits FDA Sunscreen Regulations Delay

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An online report faults FDA for taking more than 30 years to approve new sunscreen regulations.

Teva, Onco Genex Begin Phase 3 Trial in Metastatic Prostate Cancer

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Teva Pharmaceuticals and Onco Genex Pharmaceuticals initiate a Phase 3 trial SYNERGY to evaluate custirsen as as first line therap...

Novartis Agrees to Pay $423 Million in Off-label Case

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Novartis Pharmaceuticals agrees to pay $423 million in criminal and civil fines to resolve a U.S. Attorney's Office (Eastern Distr...

Caution Urged on Regulating Lab Tests

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The American Clinical Laboratory Association and the Genetic Alliance urge FDA to use notice and comment rulemaking to develop a r...

Another Top CDRH Official Leaves the Agency

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CDRH 510(k) staff director Heather Rosecrans retires from the agency and joins other former FDAers at regulatory consulting firm G...

FDA Amends IND Safety Reporting Requirements

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Federal Register Final rule: FDA amends its regulations on safety reporting requirements for drugs and biologics subject to an inv...

Guidance on Safety Reporting for INDS and BA/BE Studies

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Federal Register Notice: FDA releases a draft guidance on safety reporting requirements for investigational new drugs and bioavail...

FDA Warns Consumers About Infant Sleep Positioners

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FDA warns consumers to stop using infant sleep positioners due to suffocation risks.

Pfizer Stops Sutent Prostate Cancer Trial

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Pfizer ends a Sutent prostate cancer trial when no benefit is seen in an interim analysis.