Drug Discovery World

AUGUST 24, 2023

In the second part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of psilocybin in drug discovery. Moreover, the US Food and Drug Administration (FDA) granted breakthrough therapy status to psilocybin in 2018 for treatment-resistant depression, and in 2019 for major depressive disorder 4.

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Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. Investigational New Drug, or IND, safety reports) to the FDA in E2B(R3) format.

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Agency IQ

AUGUST 4, 2023

The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation. The FMD will “disapply” for applicable prescription drugs beginning January 1, 2025.

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Packaging Licensing Licensing Regulations 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. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need.

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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).

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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.

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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).

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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. Plaintiff does not claim that [defendant] did test [the drug] and was aware of its addictive qualities but nonetheless failed to warn its readers of that fact. Accord Stark v.

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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). 247d-6d(b)(8). Texas, the last time we looked, is a state. Plaintiffs Legal Committee , 531 U.S.

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Vaccine FDA FDA Approval Pharmacy 59

Drug & Device Law

MAY 30, 2022

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . their patients.

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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. at 172 (“continued to prescribe” the drug “a lot” and “believed it to be an effective drug for many of her patients”). Schering Corp. ,

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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. The case we report on today, Chong v. Kind LLC , — F.

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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. As we noted at the time, although the case arose in the food context, its analysis is directly applicable to drug and device cases. Today we report on another food case relevant to device, if not drug, cases, Nacarino v.

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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. The unlawful claim is based on alleged violations of the Food, Drug, and Cosmetic Act (FDCA) as incorporated in California’s Sherman Law.

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