Drug Discovery World

AUGUST 24, 2023

Within the debate, an e-petition was presented, which closed in February 2023 and received 11,824 signatures, and called on the government to reschedule psilocybin for medical research on untreatable conditions to Schedule II of the Misuse of Drugs Regulations 2001. million of the investment is dedicated to mental health research 7.

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Clinical Trials Treatment Regulations Trials 130

Agency IQ

JUNE 21, 2024

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. Chapter 4 of Directive 2001/83/EC allows Member States to recognize assessments from another E.U.

Regulations 40

Regulations Production Marketing Vaccine 40

Agency IQ

APRIL 12, 2024

Directive 2001/83/EC and Regulation (EC) No 726/2004. Additionally, reform package included revisions of the regulations for pediatric medicines and orphan drugs. Generally, all MEPs supported the package in its current form, with political affiliations shaping the provisions each highlighted. citizens; 2.

Pharmaceuticals 40

Pharmaceuticals Packaging Regulations Production 40

Agency IQ

MARCH 29, 2024

April 2024 Restoration of Inadvertently-Removed Exemption from the Requirements of FIFRA (Proposed Rule Stage) 2070-AK25 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. These standards were vacated on 7/24/2001 and on 2/13/2002. This routine Methods Update Rule (rMUR) was proposed in February 2023.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

Proposed Rule Stage Restoration of Inadvertently Removed Exemption From the Requirements of FIFRA 2070-AK25 August 2023 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. Smith rejected plaintiff’s analogy between books and drug package inserts. May 13, 2015) (contract involving multiple, identical “software package[s]” governed by UCC).

Production 52

Production International Trials Government 52

Drug & Device Law

MAY 30, 2022

2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. 2001), aff’d , 358 F.3d Stryker Co. , 3d 568, 576-77 (6th Cir. Parke, Davis & Co. ,

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. 2001) (no causation where medical personnel “had no alternative other than to use the. . . Smith & Nephew Richards, Inc. , 2d 35, 41 (D.D.C.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

JANUARY 4, 2024

341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 247d-6d(b)(8). Plaintiffs Legal Committee , 531 U.S.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Implicitly relying on 21 U.S.C. §

Packaging 72

Packaging Regulations FDA Government 72

Drug & Device Law

MARCH 10, 2022

341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. The court acknowledged that “[o]n one level, the plaintiffs may have a point,” because consumers will in fact digest less protein than indicated on the product packaging. A few weeks ago, we reported on Chong v.

Regulations 52

Regulations FDA Packaging FDA Approval 52

Drug & Device Law

JANUARY 31, 2024

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package. 341 (2001). Catalina Snacks Inc. LEXIS 9637 (N.D. But claims based on violations of the FDCA are preempted by Buckman Co.

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Packaging Production FDA Drugs 52