clinical research

Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency.  

Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 191 entitled "Changes to Approved NADAs--New NADAs vs. Category II Supplemental NADAs."  

 

The FDA has issued letters of warning to two New York food production operations suspected in violation of adulterated food brought about by misuse of animal medications. Potsdam-based Adon Farms and Lloyd T. Smith & Sons in Canton are dairy farms, and Francis J. Szarek of Westmoreland, NY runs a veal operation. The Adon dairy was inspected on April 2 and 9, 2009 and the "Warning Letter" mailed on Aug. 5, 2009.  

An international effort against the sale of counterfeit prescription drugs on the Internet shut down 72 Web sites, officials announced Friday in New York. Operation Pangea II involved Interpol, U.S. agencies and task forces from two dozen countries, Interpol said in a release. During the five-day operation that ended Friday, monitoring revealed 751 Web sites allegedly engaged in illegal activity, including offering controlled or prescription-only drugs, 72 of which were taken down, the international la  

An international effort against the sale of counterfeit prescription drugs on the Internet shut down 72 Web sites, officials announced Friday in New York. Operation Pangea II involved Interpol, U.S. agencies and task forces from two dozen countries, Interpol said in a release. During the five-day operation that ended Friday, monitoring revealed 751 Web sites allegedly engaged in illegal activity, including offering controlled or prescription-only drugs, 72 of which were taken down, the international la  

Pfizer and Boehringer Ingelheim have been boosted by the news that experts in the USA have recommended expanding the label on their chronic obstructive pulmonary disease blockbuster Spiriva. The US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee has voted 11 to 1 that clinical data included in a supplemental New Drug Application provide "substantial and convincing evidence" to support the claim that Spiriva (tiotropium) reduces exacerbations in patients with COPD. Interestingly  

Lifesaving medicines worth lakhs were being smuggled out of NRS hospital for at least four years by Group D workers, mainly of the emergency and gynaecology wards, the probe into the scam has revealed. "A section of the Group D employees of the two wards ran the racket for four years. They sold the medicines in the black market with the help of middlemen," said an officer of Muchipara police station investigating the case. Six Group D workers of the two wards have been absconding since the racket came  

Nobody quite knows, including the Food & Drug Administration. So the agency held two days of hearings in November to brainstorm about social media rules for drug companies. More than 800 people signed up for the meeting, held in a room that seats half that number, and so many attendees tweeted the proceedings that one of them set up a Web page, www.fdasm.com , to collect all the comments.  

ALLEGAN, Mich. A Michigan drugmaker is doing well even though it's located in the state with the country's highest unemployment rate. Perrigo Co. is the nation's largest manufacturer of generic over-the-counter medications. It reported more than $61 billion in profit last quarter — a 60 percent spike from the same time last year.