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TXT Cancer R&D Study Draws Advocate Fire [2826 Words] [ Price : $8.95]
Industry advocates challenge conclusions in a JAMA Internal Medicine analysis of the cost and potential revenue involved in developing one new cancer drug.
09/13/2017
 
 
TXT Draft PQ/CMC Standardization Concerns Raised [3123 Words] [ Price : $8.95]
Drug companies say FDA should do more work on its draft document on standardization of pharmaceutical quality and chemistry, manufacturing, and controls data in electronic submissions.
09/13/2017
 
 
TXT FDA Panel Backs Warning on Gadolinium-based Contrast Agents [366 Words] [ Price : $8.95]
FDAs Medical Imaging Drugs Advisory Committee votes to recommend a warning about gadolinium retention for gadolinium-based contrast agents when used during magnetic resonance imaging.
09/13/2017
 
 
TXT Woodcock Supports Reforms to OTC Monograph Program [384 Words] [ Price : $8.95]
CDER director Janet Woodcock tells a House Energy and Commerce Health Subcommittee hearing that the current monograph system for over-the-counter drug products is outdated and reforms are needed.
09/13/2017
 
 
TXT Dont Move Imodium from OTC to Rx: CHPA [2922 Words] [ Price : $8.95]
The Consumer Healthcare Products Association says there is no need for FDA to approve a change for Imodium from over-the-counter to prescription status.
09/12/2017
 
 
TXT Allergan Transfers Restasis Patents to Native American Tribe [2828 Words] [ Price : $8.95]
Allergan transfers Restasis patents to a Native American tribe to shield them from review by the U.S. Patent Trial and Appeal Board.
09/12/2017
 
 
TXT Patch Test for Allergic Contact Dermatitis Approved [135 Words] [ Price : $8.95]
FDA approves a SmartPractice PMA for its TRUE Test ready-to-use patch test panels for pediatric patients as young as six years of age for diagnosing allergic contact dermatitis.
09/12/2017
 
 
TXT Cardio Drug Approval Rates Drop 52% in 30 Years: Analysis [3101 Words] [ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis finds that the FDA approval rate for cardiovascular drugs has dropped 52% in the last 30 years, while the development time increased.
09/12/2017
 
 
TXT CGMP Violations at HomeoCare Laboratories [3090 Words] [ Price : $8.95]
FDA warns HomeoCare Laboratories about CGMP violations in its production of three misbranded homeopathic drugs.
09/12/2017
 
 
TXT Dynavision D2 Adulterated and Misbranded: FDA [2911 Words] [ Price : $8.95]
FDA warns Dynavision that its D2 device is adulterated and misbranded and fails to conform to Quality System regulation requirements.
09/12/2017
 
 
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