2001, Licensing, Marketing and Regulations

Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Providing a broad view.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA

FDA Trials Regulations Therapies

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

Packaging

Packaging Licensing Licensing Regulations

Article EMA Thank You What Europe’s proposed Data Act means for device manufacturers: A deep dive

Agency IQ

SEPTEMBER 29, 2023

The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets. Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces.

Regulations

Regulations Government Production International

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science

Science FDA Packaging Production

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

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.

Regulations

Regulations Compliance Production Science

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The illicit marijuana market remains strong despite state laws legalizing marijuana. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy.

Regulations

Regulations Production FDA Approval Marketing

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. no[r] a marketing product” under Lanham Act). 2001); Isham v. 2001), relied on these other statutes to hold that a road could not be a “product”). Leading Market Technologies, Inc. , In United States v.

Production

Production International Trials Government

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. 247d-6d(b)(8). Strike two. The suit “relates to” – at least – “the. . . development, clinical testing or investigation, . . Strike three.

Vaccine

Vaccine FDA FDA Approval Pharmacy

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 397 (6th Cir.

FDA

FDA FDA Approval Testimonials Vaccine

FDA and Off-Label Communication – Getting Closer to Truth

Drug & Device Law

NOVEMBER 9, 2023

If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. The FDA is concerned, probably with reason, about its own power.

FDA

FDA Nurses Production Regulations

Court Denies Motion to Dismiss Claims Targeting a Biologic

Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Plaintiff received the biologic just months after it had been licensed by the FDA. 341 (2001). 337(a), which applies to all products regulated under the FDCA, not 21 U.S.C. See 42 U.S.C. § See 21 C.F.R. Albrecht , 139 S.

FDA

FDA FDA Approval Licensing Licensing

Drug Discovery Digest

Preparing the next generation of drug discovery scientists

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Trending Sources

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Article EMA Thank You What Europe’s proposed Data Act means for device manufacturers: A deep dive

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

How the Fifty States View Electronic Data as a “Product”

A Texas Mess

The FDA and Feasible Alternative Designs

FDA and Off-Label Communication – Getting Closer to Truth

Court Denies Motion to Dismiss Claims Targeting a Biologic

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