Dating ru approval
The FDA has mandated that the drug be made available to women who are no more than 49 days pregnant (7 weeks from their last menstrual period). Women taking the drug must sign a form indicating they are aware of the risks associated with the RU486/PG combination for them and their baby and promising to return for additional visits on day 3 (to take the prostaglandin) and about day 14 (to determine whether or not the abortion has taken place). “I really only have one comment, and that is that the decision does not rest with me,” Ambrose told reporters in Edmonton Thursday.”It’s out of my hands and the decision is final.” When asked specifics about the drug, Ambrose said, “Any of those details you would have to speak to the officials at Health Canada and the scientists that actually managed the regulatory approval process.Anti-abortion forces threaten Roussel Uclaf's parent company, Hoechst AG, with economic reprisal if RU486 is marketed in the United States.1989 In March, Hoechst informs abortion opponents that "it is not our intention to market or distribute RU486 outside of France." The U. Food and Drug Administration responds to pressure from anti-abortion Congressional representatives by banning the importation of RU486 for personal use.
1988 RU486 becomes available in France in October 1988, after the French Minister of Health declares RU486 "the moral property of women" and orders Roussel Uclaf to return RU486 to the market following the company's decision to withdraw the drug in the wake of anti-abortion pressure.Though the FDA decided against dropping the second visit to the doctor to take the prostaglandin on day 3, it did drop the requirement, in place during American trials of the drug, that women stay at the clinic for four hours after taking that drug. Because of the looser regulations, physicians considering prescription of RU486 no longer need to worry about getting special training, buying expensive medical equipment, or disrupting their medical practices. FDA "Office Memo to Population Council," gov/cder/drug/infopage/mifepristone/, p. The Feminist Majority Foundation launches the nation's largest public education drive on RU486, the Campaign for RU486 and Contraceptive Research. At these meetings, which include a five-hour discussion with Roussel CEO Edouard Sakiz, the delegation presents over 115,000 petitions from American citizens in support of RU486.JULY 1990 A ten-member Feminist Majority Foundation delegation, comprised feminist leaders and prominent scientists, travels to Europe to meet with officials of Roussel Uclaf and Hoechst AG, respectively, to urge U. NOVEMBER 1990 Congressman Ron Wyden holds hearings on RU486 before the House Small Business Committee.
While the original regulations would have limited prescription of the drug to physicians who had the surgical training to handle incomplete abortions or serious complications sometimes associated with the drug, current measures require only that a physician not having such skills make arrangements with some other physician with the appropriate surgical training.