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- FDA eases approval rules for drug makers.(Industry Newsline)
- Under new guidelines designed to prevent supply disruptions, drug makers will not need regulatory approval for every change in their manufacturing processes, the U.S. Food and Drug Administration said last month. In a report detailing its two-year ef Under new guidelines designed to prevent supply disruptions,...
- Research articles 2004-10-01
- Administration urged to restore use tests on pediatric drugs. (Markets).(Brief Article)
- A BIPARTISAN group of senators has asked the Bush administration to restore a federal regulation requires drug firms to test their products for use by children. In a letter to Health and Human Services Secretary Tommy Thompson, the lawmakers ...
- Research articles 2002-04-22
- Administration, Pharma Groups Support Renewal of Pediatric Testing Measure.(Government Activity)(Brief Article)
- THE BUSH ADMINISTRATION joined thc pharmaceutical industry and patient groups last week in calling for Congress to promptly renew a four-year-old law that gives drug companies incentives to study the effects of medicines on children, an area long n THE BUSH ADMINISTRATION joined thc...
- Research articles 2001-05-14
- FDA Not to Restrict Pharma Makers From Promoting Unapproved Medicine Uses.
- IN A MAJOR VICTORY for drug companies, a federal judge has ruled that the government cannot restrict certain promotional activities by the pharmaceutical industry that encourage unapproved uses of their medicines. US District Judge Royce Lamb IN A...
- Research articles 1999-08-09
- Allergy, OTC Drug Fight Far from Settled.(over the counter)(Brief Article)
- ALTHOUGH A FEDERAL advisory panel has decided that three popular allergy drugs are safe enough to be sold without a prescription, industry analysts said last week that brand-name drug companies will likely use the court system to prevent a switch t ALTHOUGH A FEDERAL...
- Research articles 2001-05-21
- FDA Seeks Advice From Blogger; Google Solves Pharma's Ad Problems
- The FDA sought the advice of John Mack, a blogger with 20,000 monthly readers who runs the Pharma Marketing Blog, on how drug companies should use the web to advertise their products. The agency usually likes to hear from lawyers, drug company executives and academics when it seeks regulatory advice....
- Blog posts 2009-11-12
- Glaxo Gets an FDA Warning... With Teeth
- Well before Vytorin became a cause célèbre -- which is to say, about a year ago -- GlaxoSmithKline was the drugmaker getting slapped around by critics for downplaying or ignoring possible heart problems associated with its diabetes drug Avandia. That case, which led to new warnings on the drug's label...
- Blog posts 2008-04-12
- BNET Focus on Antidepressants: Part 2, Controversies
- While the antidepressant market is both robust and lucrative, as we saw in part 1 of this three-part series, it is also controversial. No drug category is so dogged by doubts and questions, and yet so widely prescribed, as antidepressants. The most recent major event in the...
- Blog posts 2008-10-01
- 14 Drug Companies Cited for Misleading Google Ads
- The FDA cited 14 drug companies for misleading advertising in sponsored ads among Google search results. Those cited: Biogen Idec, Sanofi Aventis, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer, Johnson & Johnson, Pfizer, Novartis , Genentech, Boehringer Ingelheim, Merck, Hoffman-LaRoche, and Eli Lilly. The citations, sent...
- Blog posts 2009-04-07
- FDA to Allow "Off-Label" Unapproved Drug Promotion
- The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature discussing off-label uses. Drug companies and their right-wing stalking horse, the Washington Legal Foundation, have been pushing for this move for years....
- Blog posts 2009-01-13
- Drug Makers Gave Lobbyists an Xmas Gift -- Millions More to Lobby Obama Administration
- A New Year will bring a new president, a new FDA chief, many new drug regulations, and, possibly, health insurance reform. Mindful of the ton of major drug brands that will go off-patent in 2009, drug companies have not rested in their lobbying efforts over generics and patent issues. They...
- Blog posts 2008-12-31
- FDA Caves to Pfizer, Industry on Antibiotics Ruling
- The Food and Drug Administration has quietly withdrawn its order banning extralabel use of the antibiotic cephalosporin, so that it can "fully consider the comments" it has received on the issue. When the agency announced the order on July 3, drug companies and agriculture groups were outraged....
- Blog posts 2008-12-12
Additional Resources
- FDA Expands Use of Convera Search Technology for Drug Review and Approval Process
- VIENNA, Va. -- Convera (NASDAQ:CNVR), a leading provider of search and categorization software for enterprises and government agencies, today announced expanded use of the company's RetrievalWare search technology by approximately 2,500 scientific review staff within the Center for Drug Evaluation and Research CDER at the FDA. The FDA's CDER uses...
- Research articles 2004-06-22
- XOMA to present at BIO 2005 Annual International Conference and FDA accepts Neurocrine New Drug Application.
- M2 PRESSWIRE-14 June 2005-US Financial Network: XOMA to present at BIO 2005 Annual International Conference and FDA accepts Neurocrine New Drug ApplicationC1994-2005 M2 COMMUNICATIONS LTD RDATE:14062005 City of Industry, CA - Biotechnology industry news provide by Financial News USA (OTC: FNWU)....
- Research articles 2005-06-14
- The 10 Weirdest Drug Stories of the Month
- A vaccine for smoking! Power hungry Eli Lilly execs! Flu shots from caterpillars! It all happened in November 2009. Biogen CEO pay = $148 million for 6 years Letter to the SEC: "CEO, James Mullen, has sold more than $85 million of stock, which we estimate...
- Blog posts 2009-12-02
- Centex Construction Company Awarded FDA Center for Drug Evaluation and Research Office Tenant Buildout
- FAIRFAX, Va. -- Centex Construction Company's Mid Atlantic Division has received a $21 million contract to perform the tenant buildout for the Food and Drug Administration FDA within the Center for Drug Evaluation and Research CDER office building in White Oak, Md. The contract was awarded by the U.S. General...
- Research articles 2004-12-16
- Expert in Pharmaceutical Sciences and New Drug Applications to FDA Joins PhytoMedical
- PhytoMedical continues product expansion and accelerated development of type-2 compound; Company adds FDA-submission/Pharmacology expertise to Advisory Board.
- Research articles 2007-02-21
- Q&A: Peter Rost on His Quixotic Bid to Become Obama's FDA Chief
- Pfizer whistleblower and compulsive blogger Peter Rost has tossed his Panama hat into the ring for the post of FDA commissioner in the new Obama administration. He's got the "backing" -- or at least the paperwork -- of Sen. Sherrod Brown and Rep. Jo Ann Emerson. Rost...
- Blog posts 2008-12-04
- The 10 Weirdest Drug Stories of the Month
- Another month has passed so it's time once again to look at the pharmaceutical news that didn't deserve a headline but was still too strange to be ignored. Here are BNET's 10 Weirdest Drug Stories of October 2008: Malaria cure is now cherry flavored Novartis has...
- Blog posts 2008-11-03
- FDA Loosens Rules for Overseas Drug Trials
- Merrill Goozner, a former Chicago Tribune reporter turned public-health advocate he heads up the Integrity in Science Project at the Center for Science in the Public Interest, notes an interesting and almost wholly overlooked Food and Drug Administration decision that may have the effect of subjecting clinical-trial volunteers in poor...
- Blog posts 2008-05-08
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