Drug Discovery World

FEBRUARY 20, 2024

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. Ther Innov Regul Sci. BMJ 2003; 327: 484-487. DDW Volume 25 – Issue 1, Winter 2023/2024 References Rogers CA, Ahearn JD and Bartlett MG. 2020; 54: 1123-1133.

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Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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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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Agency IQ

JANUARY 4, 2024

What we expect the EPA to do in January 2024 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. Major barriers still persist.

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Policy Prescription

MARCH 12, 2021

Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). State of Reform does a nice job covering this bill, but this post gives some underlying and important history.

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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

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , 2003) (a court that “permits [an expert] to testify as an expert without first determining whether he or she has a sufficient basis” is “abdicating its evidentiary gatekeeping responsibilities”) (footnote omitted). Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. Cooper , 496 P.3d

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Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

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Drug & Device Law

JANUARY 17, 2022

we use[] a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command. Thus, we’re pleased to bring to your attention Pharmaceutical Care Management Association v. 470, 485 (1996). 702 in a non-prescription medical product case. Wehbi , 18 F.4th Wehbi , 18 F.4th

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Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Kent , 552 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. So we ran a search. at *12-13.

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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. 644 (2003), but not to Pike. Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. 501 (1912).

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