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Medical Devices

QS Issues Found at American Contract Systems

FDA warns American Contract Systems about Quality System violations in its work as a medical device manufacturer and contract sterilizer.

Human Drugs

Drug Safety Alert on Novartis MS Drug Gilenya

A new FDA drug safety alert warns that when Novartis multiple sclerosis drug Gilenya (fingolimod) is stopped, the disease can become much worse than b...

Human Drugs

Sanders, Khanna Plan Drug Price Relief Legislation

Sen. Bernie Sanders and Rep. Ro Khanna say the will introduce legislation aimed at forcing drug companies to reduce the price for branded prescription...

Human Drugs

FDA Approves Elite Pharma Generic Norco

FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).

Federal Register

New Info Collection on Cosmetic GMP Survey

Federal Register notice: FDA submits to OMB a new information collection entitled Survey of Current Manufacturing Practices for the Cosmetics Industry...

Federal Register

Comments Sought on Drug Sponsor Disseminated Software

Federal Register notice: FDA seeks comments on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include American Contract Systems, Product Packaging and Surmasis Pharmaceutical.

Human Drugs

Angiotensin II Receptor Blocker Impurities Q&A

FDA posts questions and answers about the presence of suspected carcinogenic impurities in some generic versions of valsartan drug products.

Human Drugs

Gamifant OKd for Hemophagocytic Lymphohistiocytosis

FDA approves Novimmunes Gamifant (emapalumab) for treating pediatric and adult patients with primary hemophagocytic lymphohistiocytosis who have refra...

Marketing

Watchdog Says Cancer Centers Use Misleading Ads

The Truth in Advertising watchdog group says that many major cancer centers use misleading testimonials touting atypical results in their promotional ...