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☆ Read the Court Decision Invalidating F.D.A. Approval of Mifepristone
▼ + stars: | 2023-04-08 | by ( ) www.nytimes.com time to read: +3 min

1985) (concluding FDA's denial was not arbitrary and capricious because the proposed labeling did not "specify conditions of use that are similar to those followed in the studies"). "The scope of review under the arbitrary and capricious standard is narrow and a court is not to substitute its judgment for that of the agency." 48 Plaintiffs also frame what the Court characterized as the “study-match problem" as a statutory violation of the FFDCA. § 355(d) as necessarily requiring an exact "match" between trial conditions and the conditions on the approved labeling of a new drug. Thus, even if Defendants could survive "arbitrary and capricious" analysis of the "study-match problem," Defendants still violated Section 355(d) on their own terms.

☆ With Dueling Rulings, Abortion Pill Cases Appear Headed to the Supreme Court
▼ + stars: | 2023-04-08 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

WASHINGTON — The dramatic dueling rulings by two federal district judges on Friday about access to a widely used abortion pill set up a lower court conflict that legal experts say will almost certainly send the dispute to the Supreme Court. “It really turbocharges the imperative for the Supreme Court to step in and to do so sooner rather than later,” said Stephen I. Vladeck, a law professor at the University of Texas at Austin. A federal judge in Texas issued a preliminary ruling on Friday invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, which could make it more difficult for patients across the country to access the medication. Less than an hour later, a federal judge in Washington State issued a ruling in another case that contradicted the Texas judge by ordering the F.D.A. The Texas judge, Matthew J. Kacsmaryk, an appointee of President Donald J. Trump, stayed his order for seven days to allow the F.D.A.

☆ Read the Court Decision Ordering the F.D.A. to Keep Mifepristone Available
▼ + stars: | 2023-04-07 | by ( ) www.nytimes.com time to read: +2 min

Plaintiffs contend that mifepristone no longer requires a REMS program 8 with ETASU. Plaintiffs assert that (1) 2 3 4 5 Case 1:23-cv-03026-TOR 7 ECF No. Defendants do not address whether mifepristone qualifies 16 for ETASU, asserting it need only determine whether modifications are appropriate 17 under 21 U.S.C. See ECF Nos. 51 at 25; 78 at 22.

☆ A Psychedelics Pioneer Takes the Ultimate Trip
▼ + stars: | 2023-04-03 | by ( David Marchese | ) www.nytimes.com time to read: +15 min

Mamadi Doumbouya for The New York Times Talk A Psychedelics Pioneer Takes the Ultimate TripAs the founding director of the Johns Hopkins Center for Psychedelic and Consciousness Research, Dr. Roland Griffiths has been a pioneer in investigating the ways in which psychedelics can help treat depression, addiction and, in patients with a life-threatening cancer diagnosis, psychological distress. He has also looked at how the use of psychedelics can produce transformative and long-lasting feelings of human interconnectedness and unity. “So I believe that in principle we shouldn’t need this Stage 4 cancer diagnosis to awaken. Is your perspective maybe one that a 40-year-old, say, with a terminal cancer diagnosis would be able to inhabit so profoundly? If I had a regret, it’s that I didn’t wake up as much as I have without a cancer diagnosis.

Small icons of scientific papers are lined up in a grid, each representing a study of medication abortion. Studies of abortion pills Each icon represents one study that reported serious complications after medication abortion. For pregnant women considering medication abortion, the alternatives would be childbirth or procedural abortion. Almost all patients will experience bleeding and pain during a medication abortion, because the pills essentially trigger a miscarriage. But the study itself notes that bleeding is expected, serious complications are rare and medication abortion is safe.

☆ Your Data Is Diminishing Your Freedom
▼ + stars: | 2023-03-20 | by ( David Marchese | ) www.nytimes.com time to read: +13 min

What inequalities are baked into these data systems? Oregon State UniversityBut it’s almost impossible to function in the world without participating in these data systems that we’re told are mandatory. Which is a concern with, How are these data systems proscribing my freedoms? This is the question of equality and the implications of these data systems’ being obligatory. You get these data systems that load people in, but it’s clear there wasn’t sufficient care taken for the unequal effects of this datafication.

☆ Where Restrictions on Abortion Pills Could Matter Most
▼ + stars: | 2023-03-02 | by ( Allison Mccann | Amy Schoenfeld Walker | ) www.nytimes.com time to read: +10 min

Abortion providers in the United States A United States map shows the location of abortion providers in states without abortion bans. total abortions Medication abortions 71,700 61,500 58% 37,500 32,100 28,800 29,500 41% 61% 60% 51% 52% Florida New York Georgia Pa. Mich. N.C. N.J. Ohio Wash. Mass. Some ways the ruling could affect the availability of abortion pills A flowchart shows possible outcomes from a judge’s ruling and highlights how abortion pills could remain available under some scenarios. Even if the judge rules in favor of the plaintiffs, abortion pills could remain available. The foundation’s Wichita, Kansas, clinic sees more than 500 patients a month, many from Texas, and 60 percent choose abortion pills.

☆ Should You Get Another Covid Booster?
▼ + stars: | 2022-03-29 | by ( ) www.nytimes.com time to read: +12 min

to authorize a second booster shot of its vaccine — that is, a fourth dose — for people aged 65 and older. Two days later, Moderna followed suit, but with a broader request to authorize a second booster for all adults over 18. The agency said on Tuesday that adults aged 50 and older could opt for a second booster shot of the vaccines made by Pfizer-BioNTech or Moderna, to be given at least four months after the first booster of any authorized or approved Covid vaccine. A second booster would be the third shot for those who received one dose of the Johnson & Johnson vaccine and a booster shot of an mRNA vaccine. In fact, other data from Israel suggests that a second booster has only marginal benefits in healthy young people.

☆ 7 000 de doze de Remdesivir, pentru tratamentul pacienților cu COVID-19, au ajuns în R. Moldova. Autoritățile au anunțat unde vor merge medicamentele
▼ + stars: | 2020-11-18 | by ( ) www.zdg.md time to read: +2 min

Responsabilii din cadrul Ministerului Sănătății au anunțat miercuri dimineață, 18 noiembrie, șapte mii de flacoane de Remdesivir, primul medicament autorizat pentru tratamentul pacienților infectați cu noul tip de coronavirus, au ajuns în Republica Moldova. Potrivit Ministerului Sănătății, lotul de 7000 flacoane de Remdesivir a fost achiziționat de Centrul pentru Achiziţii Publice Centralizate în Sănătate pentru tratamentul în staționar a pacienților cu forme moderate de COVID-19 și urmează să fie repartizat instituțiilor medico-sanitare publice din țară. Totodată, reprezentanții MSMPA menționează că, cu suportul Organizației Mondiale a Sănătății (OMS), vor fi organizate instruiri în toate spitalele din țară privind utilizarea corectă a medicamentului Remdesivir în tratamentul pacienților infectați cu COVID-19. La 3 iulie, Remdesivir a devenit primul tratament autorizat, acesta primind o autorizație de introducere pe piață condiționată. În Republica Moldova, preparatul Remdesivir este prevăzut în Protocolul clinic național provizoriu „Infecția cu coronavirus de tip nou”, utilizat în tratamentul pacienților infectați cu virusul SARS COV-2.

Persons: Remdesivir Organizations: Ministerului Sănătății, Sănătății, Organizației Mondiale a Sănătății ( OMS, Autoritatea Locations: Republica Moldova, Moldova, Statele Unite ale Americii, REMDESIVIR, SUA

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