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Human Drugs

Recall NDMA-Contaminated Metformin: Valisure

Online pharmacy and testing laboratory Valisure says it has detected NDMA contamination in some lots of metformin from several companies.

Human Drugs

Median Drug Development Cost is $985 Million: Study

Researchers say the median cost for developing a new drug between 2009 and 2018 was $985 million.

Human Drugs

Mallinckrodt Sued Over Rebate Issue After New Indication

The U.S. government files a False Claims Act suit against Mallinckrodt ARD (previously Questcor Pharmaceuticals) for allegedly underpaying Medicaid re...

Human Drugs

FDA Requires Singulair Boxed Warning

FDA orders a Boxed Warning to be added to labeling for Mercks Singulair and its generic forms on the risk of neuropsychiatric events.

Government Coronavirus Response: A Series of Missteps

FDA Webview examines a series of avoidable missteps by federal agencies and the Trump Administration in responding to the current coronavirus outbreak...

Medical Devices

Biogennix Gains Expanded Indication for Agilon

FDA clears a Biogennix 510(k) for an expanded indication for its Agilon moldable bone grafting product use in posterolateral spine procedures when mi...

Federal Register

Meeting on Cosmetics International Regulation

Federal Register notice: FDA announces a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation (ICCR) Preparation for ICCR14...

Federal Register

43 Product-Specific ANDA Guidances Posted

Federal Register notice: FDA makes available 43 product-specific guidances for generic drug developers.

Federal Register

Guide on Bone Anchor 510(k)s

Federal Register notice: FDA makes available a final guidance entitled Bone Anchors Premarket Notification (510(k)) Submissions.

Human Drugs

Market America Multiple Supplement Violations

FDA warns Market America about violations in its distribution of contract-manufactured dietary supplements.