Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients.

Science 40

Science FDA Packaging Production 40

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important.

FDA 52

FDA FDA Approval Doctors Production 52

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” 341 (2001), is so important.

FDA Approval 59

FDA Approval FDA Doctors Production 59

Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , What’s worse, the fraud on the FDA claim, if brought under state law, would be preempted by Buckman Co. 341 (2001).

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

JANUARY 9, 2023

Bayer Healthcare Pharmaceuticals Inc. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). The FDA also promulgated an acetaminophen-specific OTC regulation. Just compare the felicitous result in Truss v. 2022 WL 16951538 (S.D.N.Y.

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. Danco Labs.,

FDA 59

FDA FDA Approval Pharmaceuticals Clinical Trials 59

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S.

FDA 72

FDA Regulations Production Government 72