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U.S. Food and Drug Administration
... Welcome'' is a condemnation of blood donation rules set by the Food and Drug Administration that prohibit most gay or bisexual men from giving; before ...
... $14.5 billion, according to the U.S. Bureau of Labor Statistics. The Food and Drug Administration had no immediate comment on whether any drug shortages could ...
... 12th Annual FDA Inspections Summit: Flawless FDA Inspection Handling and Response Preconference Workshop **Presented by ...
... Opportunities for Women and the Women's Equity Action League. Clarence Evans Jr., FDA official Clarence Evans Jr., 89, a Washington-area dermatologist for over 40 years ...
... asbestiform minerals and to conform to cosmetic talc requirements." "The U.S. Food and Drug Administration requires specific testing to ensure that cosmetic talcum powder is ...
... Could the Food and Drug Administration classify the Apple Watch as a medical device? It’s a ...
... FDCA. During this time period, Juxtapid was approved by the U.S. Food and Drug Administration (FDA) to treat patients with homozygous familial hypercholesterolemia (HoFH), a ...
... cleared the Pharmacy and Poisons Board (the equivalent of the U.S. Food and Drug Administration) and could be sold in several African countries. (The blanket ...
... promoted Juxtapid to doctors and patients despite the fact that the Food and Drug Administration had approved it only for treatment of extremely high cholesterol ...
... scope with a disposable cap for use in the U.S. The Food and Drug Administration said that the design of the new duodenoscope by Japanese ...
... there may be some significant regulatory hurdles for these apps. While the FDA has issued extensive guidance for mobile medical applications, many, if they provide ...
... American artisan cheeses have been kept off market shelves too as the FDA struggled for the last two decades to devise regulations over bacteria in ...
... received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of sirukumab for the ...
... in our thoughts. I also want to extend my thanks to the FDA staff in our San Juan office who worked hard to prepare and ...
... consent decree includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial ...
... chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under the FDA's accelerated approval regulations based on tumor response rate and durability of response. ...
... Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for treatment ...
... reports of additional patient deaths and a warning by the U.S. Food and Drug Administration. On Thursday, the FDA said it has identified 19 deaths ...
... Amedica's Taurus(TM) Pedicle Screw System, a spine fixation product line that received FDA clearance in November 2016, has now shifted to the Beta launch phase ...
... its Phase 3 trial and preparing for discussions with the U.S. Food and Drug Administration (FDA) regarding, as appropriate, the submission of a Biologics License ...
... a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA) for ...
... of 70.04. On August 29th, 2017, Abeona Therapeutics announced that the US FDA has granted Breakthrough Therapy designation status to the Company's EB-101 gene therapy ...
... based in Malvern, makes Percocet and Opana ER, which the U.S. Food and Drug Administration has ordered be removed from the market. Johnson & Johnson ...
... expenditure coupled with growing regulation by food safety authorities such as Food and Drug Administration (FDA) is leading the expansion of the market in this ...
... company, announced today it has received United States Food and Drug Administration ("FDA") clearance to legally market and sell MediClear(TradeMark) PreOp in the US to ...
... system. And, they must create a risk management system to satisfy the FDA and international regulators. Devicemaker Quality Compliance: Using Risk Management to Improve Design ...
... among which 150 within the study, will be eligible for this coverage. FDA authorization to start a trial in metastatic breast cancer treatment associating immunotherapy ...
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