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Human Drugs

Consent Decree Against Violative Drug Compounder

A federal judge in Arkansas enters a consent decree of permanent injunction between FDA and drug compounder Cantrell Drug Co. and its CEO James L. McC...

FDA General

Arthritis Advisory Committee Renewed for 2 Years

Federal Register notice: FDA announces the renewal of its Arthritis Advisory Committee for an additional two years beyond the charter expiration date.

Human Drugs

FTC Appeals Shire Vancocin Case Dismissal

Attorney Jennifer Thomas says the FTC decision to appeal an adverse ruling in its Vancocin case against Shire demonstrates its concern with the lower ...

Federal Register

Draft Guide on Inhalation Drug Products

Federal Register notice: FDA makes available a draft guidance entitled Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Quality ...

Medical Devices

SpeeDx M. genitalium Test Cleared by FDA

FDA clears a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects M. genitalium and genetic mar...

Medical Devices

Court Says Lap-Band Claims Preempted

Attorney Michelle Yeary says an Alabama federal court has ruled that all of a plaintiffs claims against Allergan charging negligence and other issues ...

Human Drugs

Advisors Unanimously Back GW Cannabidiol Drug

The FDA Central Nervous System Drugs Advisory Committee unanimously recommends approval of GW Pharmas Epidiolex, a cannabidiol drug to treat to rare c...

Human Drugs

Reviewers Voice Olumiant Safety Concerns

FDA medical reviewers tell members of the Arthritis Advisory Committee they have serious safety concerns about Lillys proposed arthritis drug Olumiant...

Medical Devices

Arthrosurface Shoulder Device Cleared by FDA

FDA clears an Arthrosurface 510(k) to market the OVOMotion Shoulder Arthroplasty System that the company says is intended to provide surgeons with an ...

Human Drugs

AstraZenecas Tagrisso OKd for First-line Lung Cancer

FDA expands approval for AstraZenecas Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose...