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By New York Times | June 10, 1991
WASHINGTON -- With the goal of restoring credibility after a decade of budget cuts and deregulation, the Food and Drug Administration is about to begin a sweeping review of hundreds of food and drug safety measures it has proposed in the last 30 years but never acted on.The review is the second phase of efforts by the FDA's new commissioner, Dr. David Kessler, to rebuild the agency. The first phase, which began several months ago, was increasedenforcement actions against food and drug manufacturers.
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By BLOOMBERG NEWS | December 27, 2000
WASHINGTON - Genentech Inc., the world's oldest biotechnology company, was cited by the Food and Drug Administration for quality-control lapses, most related to production of its Pulmozyme drug for cystic fibrosis. The FDA sent the warning letter, dated Dec. 14 and released yesterday, to Dr. Susan Hellman, Genentech's chief medical officer, based on an inspection of company facilities in South San Francisco, Calif., from Aug. 7 to Aug. 24. Genentech used expired material to manufacture Pulmozyme in January, the FDA said in the letter, and failed to obtain approval before distributing two bulk lots of Pulmozyme that had been contaminated and then refiltered.
NEWS
By LOS ANGELES TIMES | December 11, 1996
WASHINGTON -- The Food and Drug Administration nearly doubled the approval rate of new "breakthrough" drugs this year and reduced the review process time by half, outgoing FDA Commissioner David A. Kessler said yesterday in his annual "state of the FDA" speech.For fiscal 1996, which ended Oct. 1, 46 of the breakthrough drugs were approved, he said in a speech to the nonpartisan Food and Drug Law Institute. Moreover, the average review time dropped to about 15 months from the 30 months it took in the late 1980s, he said.
NEWS
By Kathleen Kerr and Kathleen Kerr,NEWSDAY | October 26, 2004
While the government has blamed only one company for unsafe production practices in the flu vaccine crisis, federal records show health officials knew for years that vaccine makers were having problems meeting federal health standards. Since 2000, Food and Drug Administration officials have warned at least three flu vaccine manufacturers that their plants posed health hazards and did not comply with federal regulations, government records show. In one case, the FDA fined a vaccine maker $30 million for failing to satisfy government standards at two of its plants.
NEWS
By NEWSDAY | September 22, 1999
More than 10 years after a Food and Drug Administration committee introduced the concept of informed consent for approved drugs, the agency's officials still don't know if their strategies for issuing drug warnings are working.And critics say the FDA's uncertainty is just one more symptom of an entire system in shambles."The recommendations are out there, and the FDA can point to them on paper," said Bruce Psaty, an associate professor of medicine at the University of Washington. "But what's the evidence that they work?"
NEWS
By Julie Bell and Julie Bell,SUN STAFF | April 18, 2003
Nearly two years after the death of a research volunteer at the Johns Hopkins School of Medicine, the Food and Drug Administration has concluded that the physician conducting the experiment violated federal regulations and asked that he restrict his research. Dr. Alkis Togias has given a copy of the FDA's March 31 warning letter to the school. Togias is negotiating with the FDA over terms of a settlement, and his once-suspended research has been restarted, according to a statement from the school.
NEWS
By Jonathan D. Rockoff and Jonathan D. Rockoff,Sun Reporter | September 21, 2007
WASHINGTON // Congress overhauled the government's drug-safety system yesterday, giving the Food and Drug Administration sweeping new powers in a bid to better protect patients from harm caused by drugs such as the painkiller Vioxx. The legislation, approved by the Senate without debate, is expected to be signed into law by President Bush. It gives the FDA new authority to investigate the performance of drugs after they go on sale and requires companies to post safety data publicly. "This ought to be reassuring for every family about the safety of their prescription drugs," said Sen. Edward M. Kennedy, the Massachusetts Democrat who chairs the Health, Education, Labor and Pensions Committee.
NEWS
By Tricia Bishop and Tricia Bishop,tricia.bishop@baltsun.com | April 11, 2009
Federal regulators won a permanent injunction this week barring a Westminster drug company and its New Jersey parent from selling more than 50 unapproved medications, mostly prescription cough and cold products. The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court on March 25 claiming that Maryland's Neilgen Pharmaceuticals, which does business under the name "Unigen," and its owner, Advent Pharmaceuticals, were selling drugs that were improperly manufactured, carried inadequate directions for use and were not FDA-approved.
NEWS
By David Kohn and David Kohn,SUN STAFF | November 28, 2004
The past few months have been tough for the Food and Drug Administration. The agency has been accused of turning a blind eye to the suicide risks of antidepressants, of being slow to recognize potentially deadly problems with Vioxx and of allowing other drugs to stay on the market despite known hazards. "They're giving a free pass to drugs on safety," said FDA safety officer Dr. David J. Graham, who raised early concerns about Vioxx and says some other popular drugs also pose too much risk.
NEWS
By Julie Bell and Julie Bell,SUN STAFF | October 16, 2004
The Food and Drug Administration issued a public health advisory yesterday and opened a campaign to warn patients, families and doctors that antidepressants can increase the risk of suicidal thoughts in children and adolescents. The moves, after months of controversy, include a requirement that manufacturers print a "black-box" warning - the FDA's strongest - at the top of the professional labels shipped with the drugs to doctors and pharmacists. The FDA also is requiring pharmacists to dispense all 32 antidepressants to patients with pamphlets that describe, in simple language approved by the FDA, the increased but relatively infrequent danger associated with the drugs.
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