Regulatory Affairs Syndicator

Philadelphia Business Journal - The Food and Drug Administration approved Merck & Co. Inc. ’s new drug application for Januvia, an oral treatment for type 2 diabetes, on Tuesday. Januvia works by enhancing a natural body system to significantly lower elevated blood sugar levels …

Phoenix Business Journal - Critical Therapeutics Inc. ’s application to sell a new asthma treatment has been accepted by the U.S. Food and Drug Administration for review. The Cambridge, Mass.-based biotechnology company (Nasdaq: CRTX) announced the news on Tuesday. Critical …

Atlanta Business Chronicle - Under the plea agreement, Albers admitted that he had sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen …

Fort Wayne Journal Gazette - Food and Drug Administration within days. But even while large-scale producers re-examine their methods, consumers are taking steps of their own, choosing to simplify their relationship to food by placing their trust in the hands of a grower they know

Argus Leader - He follows the April pronouncement from the Food and Drug Administration that smoked marijuana had no accepted medical use. Remember, FDA folks are partially funded by drug companies. They’re the ones who gave us Vioxx and kept secret research …

Medical News Today - In its September meeting 2006, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) gave a positive opinion to include the use of docetaxel in combination with the current standard treatment - cisplatin …

WSFA - Food and Drug Administration. “This is just one step in getting better prescribing information to the people who need it.” The revisions, the first since 1975, will require that package inserts include a “prominently displayed summary of key …

WSFA - Food and Drug Administration announced Thursday. The current process of drug, biologic and device approval and testing is “long, complex and expensive,” Dr. Andrew von Eschenbach, acting commissioner of the FDA, said at a news conference. “Nine out of …

Centre Daily - WASHINGTON - The government said Tuesday it is moving closer to approving meat and milk from cloned animals, drawing protests from consumer groups. The Bush administration is currently reviewing Food and Drug Administration plans to regulate cloned …

Jacksonville Business Journal - Under the plea agreement, Albers admitted that he had sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen …

Portland Business Journal - Under the plea agreement, Albers admitted that he had sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen …

WTOL-TV - (HealthDay News) — As the cost of prescription drugs continues to soar, patients and doctors alike are turning to generic alternatives. But are they the same? Yes, says the U.S. Food and Drug Administration. Generics are chemically identical to …

WAFF - (HealthDay News) — As the cost of prescription drugs continues to soar, patients and doctors alike are turning to generic alternatives. But are they the same? Yes, says the U.S. Food and Drug Administration. Generics are chemically identical to …

WSFA - Food and Drug Administration announced Thursday. The current process of drug, biologic and device approval and testing is “long, complex and expensive,” Dr. Andrew von Eschenbach, acting commissioner of the FDA, said at a news conference. “Nine out of …

Denver Business Journal - Under the plea agreement, Albers admitted that he had sold counterfeit and misbranded Neupogen to a California firm in September 2001, despite warnings and notices from the Food and Drug Administration and his own knowledge of counterfeit Neupogen …