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 40

Regulations Compliance Production Science 40

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Respir Med 2006 : 100 (7): 1139-51.

Trials 40

Trials Production Clinical Trials Government 40

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 40

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & Gene Expression and Regulation. Cell (2002).

DNA 93

DNA Cell Biology Molecular Biology Engineering 93

Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Link Gene Expression & Regulation →Genetic regulatory mechanisms in the synthesis of proteins , by Jacob F. & & Xie X.S.

DNA 52

DNA Cell Biology Engineering Molecular Biology 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 2, 2022

This has been more than us saying, in essence, that drug and device companies should get to do whatever they want without liability or that any preemption argument should carry the day. This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

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. Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations.

FDA 59

FDA FDA Approval Testimonials Vaccine 59