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Search resuls for: "Daniel Grossman"


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If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”
Persons: thalidomide, mifepristone that’s, , Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas
Like many of my colleagues, I’ve been holding my breath for the last year, since HRA Pharma, which manufactures Opill, submitted its application to the F.D.A. We now have hope that other advances could be coming to help offset restrictions on minors’ access to contraception and state-level abortion bans. under President George W. Bush approved Plan B for over-the-counter sale, but only for people 18 or older. Because of the age restriction, the product was shunted behind the pharmacy counter, where the consumer’s age could be confirmed. asked Plan B’s sponsor for additional data on people 17 and younger to show the product could be used safely and effectively by adolescents.
Persons: Roe, — Opill, I’ve, Opill, George W, Bush Organizations: Food and Drug Administration, HRA Pharma
"So many of the things in this ruling I would say are completely flawed," a researcher told Insider. But an OB-GYN told Insider the judge's interpretation of what the drug does is medically inaccurate. Mifepristone and misoprostol are used before we can even see an embryo on ultrasound," Grossman told Insider. Spreading such misinformation through an official judicial ruling, Biggs said, is "inappropriate, unethical, and jarring." It's definitely not going to help or prevent mental health harm or physical harm as it claims – it's going to do the opposite."
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