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Human Drugs

OIG Asks PhRMA Companies for Free Drugs

HHS Office of Inspector General asks Pharmaceutical and Research Manufacturers of America for its help finding companies to provide free drugs to pati...

Human Drugs

AuroMedics Pharma Recalls Ampicillin and Sulbactam Vials

AuroMedics Pharma recalls one lot of ampicillin and sulbactam for injection USP, 1.5 g in a single-dose vial due to the potential for vials to contain...

Human Drugs

FDA Releases Dr. Reddy's Establishment Report

FDA issues the establishment inspection report from a 2017 inspection at a Dr. Reddys facility in Andhra Pradesh, India.

Human Drugs

SCA Pharmaceuticals FDA-483 Released

FDA releases an FDA-483 with six observations from an inspection at SCA Pharmaceuticals.

Human Drugs

Watson Chlorthalidone ANDA Approval Still in Effect: FDA

Federal Register notice or correction: FDA corrects a notice that appeared 10/24/2017 announcing the withdrawal of 54 ANDAs, erroneously including one...

Human Drugs

Draft Guide on ANDA Submission Mistakes

FDA makes available a draft guidance entitled Good ANDA Submission Practices that highlights common, recurring deficiencies that may delay ANDA approv...

$2.4 Billion In 2017 Healthcare False Claim Settlements

The Justice Department says it received $2.4 billion in healthcare settlements and judgments in FY 2017.

Marketing

Reject DTC Tax Exemption Idea: WLF

A Washington Legal Foundation online post raises several objections to a proposal to eliminate the tax exemption for DTC advertising.

Human Drugs

FDA Warns American CryoStem About Atcell Violations

FDA warns American CryoStem about multiple violations in its production of Atcell.

Human Drugs

FDA Grand Rounds Alzheimers Webcast

FDA schedules a 1/11 online Grand Rounds on ethnicity- and gender-related differences in Alzheimers disease.