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Medical Devices

Alert on Robot Surgical Devices for Womens Cancer

FDA issues a safety alert on using robotically-assisted surgical devices in womens health procedures, including mastectomy and other cancer-related su...

Human Drugs

FDA OKs Janssens Tremfya One Press Injector

FDA approves a Janssen Pharmaceutical supplemental BLA for Tremfya (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with ...

Human Drugs

Bendeka Exclusivity Covers all Bendamustine Drugs: FDA

FDA says orphan drug exclusivity ordered by a federal court for Eagles Bendeka extends to all applications containing bendamustine, the active moiety ...

Human Drugs

CDER Office of Pharmaceutical Quality Meeting Initiatives: Report

CDERs Office of Pharmaceutical Quality says it saw record drug approval numbers in 2018.

Human Drugs

Gottlieb Updates Lawmakers on Drug Review Enhancements

FDA commissioner Scott Gottlieb outlines for U.S. House of Representative appropriators significant modernization efforts underway in CDERs Office of ...

Human Drugs

Parexel Hires FDA Oncology Center Deputy

Parexel International hires former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president.

Human Drugs

Genentechs Herceptin Hylecta Approved for Breast Cancer

FDA approves Genentechs Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early b...

Federal Register

Meeting on Rare Disease Patient Perspectives

Federal Register notice: FDA announces a public meeting and an opportunity for public comment on Patient Perspectives on the Impact of Rare Diseases: ...

Federal Register

New Address for Generic Drugs Document Room

Federal Register notice: FDA amends its regulations to reflect a change of address for CDERs Office of Generic Drugs Document Room from Rockville, MD,...

Human Drugs

PA Firm Settles False Claims Case for $4 Million

The Justice Department says Lehigh Valley Technologies, a human drug developer, is settling a False Claims Act suit charging it with fraudulently obta...