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Human Drugs

Look Into PBM Competitive Concerns: Grassley

Sen. Charles Grassley calls on the Federal Trade Commission to overcome a deadlocked vote and initiate a study into the business practices of pharmacy...

Federal Register

Draft Guide on Drug Supplier Verification Systems

Federal Register notice: FDA makes available a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certa...

Human Drugs

Zydus/Cadila Gets FDA-483 After Inspection

FDA issued Zydus Lifesciences (formerly known as Cadila Healthcare) a three-item Form FDA-483 after recently inspecting the firms Jarod, Gujarat (Indi...

Federal Register

Oncologic Panel Meeting to Review Ukoniq sNDA

Federal Register notice: FDA has announces a 4/21-22 Oncologic Drugs Advisory Committee meeting that will discuss the appropriate approach for phospha...

Human Drugs

Cape Drugs FDA-483

FDA releases the FDA-483 with four observations issued following an inspection at Annapolis, MD-based Cape Drugs.

Human Drugs

AbbVie to Submit Qulipta sNDA to Expand Indication

AbbVie says it will submit an sNDA to FDA to expand the indication for its Qulipta to include preventive treatment of chronic migraine.

Human Drugs

ODAC Meeting Signals Need for FDA Contact: Attorneys

Two Morrison Foerster attorneys describe lessons learned from an Oncologic Drugs Advisory Committee meeting that voted to recommend additional clinica...

Health Subcommittee to Review 20 FDA/Health Bills

The House Energy and Commerce Committee Health Subcommittee announces a 3/17 hearing entitled The Future of Medicine: Legislation to Encourage Innovat...

Medical Devices

FDA Clears Photon Counting Detector in CT Scanning

FDA clears a NeuroLogica 510(k) for the addition of Photon Counting Detector technology to its OmniTom Elite 16-slice computed tomography scanner.

Human Drugs

Supply Chain Act Drug Verification System Guidance

FDA publishes a draft guidance with its interpretation of requirements for verification systems for certain prescription drugs under the Drug Supply C...