FDA Panel Supports Flexibility in the Approval of Hormonal Contraceptives
13868
Government advisers yesterday recommended against setting specific requirements for the reliability of new hormonal contraceptives, saying that might keep useful products off the market.
662712
GAITHERSBURG, Maryland  - A U.S. advisory panel on Friday was divided over whether current data warrant changes to drug-coated heart stent labels for their use in patients with more medical complications unapproved for the device.
30297
U.S. regulators on Tuesday finalized a rule requiring makers of certain contraceptive gels, foams, films and inserts to carry a warning that the products do not protect against sexually transmitted diseases, including AIDS.
459144
The first birth control pill designed to stop monthly periods has been approved for use in the US.
182267
The U.S. Food and Drug  Administration and Barr Pharmaceuticals Inc.  will meet  to discuss the possible approval of nonprescription sales of  the Plan B "morning-after" contraceptive to women 18 and older,  the agency said on Monday.
371604
Letrozole tablets (Femara-Novartis) have been approved by FDA for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant tamoxifen therapy for 5 years.
625730
The first drug to treat female sexual dysfunction isn&#39;t ready for the market yet because of safety concerns, a federal advisory committee cautioned Thursday.
582851
A panel of experts will meet on Tuesday to consider whether the Food and Drug Administration should approve Sanofi-Aventis' experimental bird flu vaccine, which could become the first such product cleared for the U.S. market.
556543
A contraceptive drug that avoids the side effects of hormonal birth control is on the horizon, say scientists.
656231
The U.S. House of Representatives  approved a bill on Wednesday aimed at strengthening Food and  Drug Administration drug safety oversight and raising  pharmaceutical industry fees that help speed product reviews.
379737
Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
767854
Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
708813
An FDA advisory panel votes favorably on Adolor's lead drug.
466023
WASHINGTON (CBS.MW) -- An advisory panel to the US Food and Drug Administration will meet Thursday to review the safety and effectiveness of Procter &amp; Gamble&#39;s testosterone transdermal patch, heralded as &quot;Viagra&quot; for women.
44020
Nearly 20 percent of U.S. Food and  Drug Administration scientists surveyed in late 2002 said they  were pressured to approve or recommend approval of a medicine  despite their reservations about the drug's risks or  effectiveness, according to documents made public on Thursday.
619912
International family planning groups cut off from aid because of their position on abortion could gain access to U.S.-donated contraceptives under legislation approved by a House panel Tuesday.
263582
A panel of experts advising the US Food and Drug Administration recommended Wednesday that the agency approve Aventis Pasteur&#39;s long-acting Menactra vaccine against bacterial meningitis.