Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

Kirschenbaum — The law permitting the importation of cheaper prescription drugs from Canada—Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act)—has been on the books for decades. The final rule permitted FDA to solicit Section 804 Importation Programs (SIPs) from States and Tribes to import prescription drugs from Canada.

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Policy Prescription

MARCH 12, 2021

This past week, to lower drug costs, a bill was introduced in the Colorado legislature – SENATE BILL 21-123 – to allow drug imports from countries other than Canada. Colorado, which passed a law in 2019 allowing drug importation from Canada, apparently wants access to even lower cost drugs than Canada can offer.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). Medicis Pharmaceutical Corp. ,

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Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. to determine whether a proposed alternative drug would have received FDA approval.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market.

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Drug & Device Law

JANUARY 30, 2023

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S. Bartlett , 570 U.S.

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Drug & Device Law

NOVEMBER 16, 2023

GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). Based on its own in camera review of the documents, the court “fail[ed] to see” how “what JAMA editors or government regulators thought about [the article] is relevant to the causation question” in the plaintiff’s “underlying lawsuit.” The court granted the motion and JAMA appealed.

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Drug & Device Law

MARCH 28, 2022

Ferring Pharmaceuticals, Inc. A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. 2003 WL 22416000, at *4 (E.D. High on the list was Tsao v.

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Testimonials FDA Regulations Production 59

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

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