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Human Drugs

Court Blocks Dr. Reddys Suboxone Generic

A New Jersey federal court blocks Dr. Reddys launch of a generic form of Indiviors Suboxone.

Human Drugs

Learn Drug Shortage Root Causes: Senators

A bipartisan group of senators asks FDA for a report to Congress on the root causes of drug shortages.

Medical Devices

FDA Wants Precertification Pilot Input

FDA solicits stakeholder input on the latest version of its software precertification program working model.

Federal Register

Several Information Collections Approved by OMB

Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.

Federal Register

Draft Guide on Nonclinical Anticancer Trials

Federal Register notice: FDA makes available a draft guidance entitled S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers...

Medical Devices

FDA Clears B. Brauns Perfusor Syringe Pump

FDA clears a B. Braun Medical 510(k) for its wireless second generation software for its Perfusor Space Syringe Pump.

Human Drugs

Progress Seen in 3 Drug Shortages

CDER deputy director Douglas Throckmorton describes agency efforts to ease shortages of IV fluids, injectable opioid analgesics, and EpiPen.

Human Drugs

Avoid Tissue Agnostic Therapy Unintended Consequence: PhRMA

Stakeholders suggest things to be considered in developing tissue agnostic therapies.

Human Drugs

Clinical Hold Placed on Ziopharm Leukemia Trial

FDA issues a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and reques...

Human Drugs

Complete Response Letter on Ortho Psoriasis Lotion

FDA issues Ortho Dermatologics a complete response letter on its NDA for Duobrii (halobetasol propionate and tazarotene) lotion and its use in treatin...