Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JULY 28, 2023

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. But despite the law’s age, it is not yet fully operational. We’ll be most interested to see how FDA plans to handle these risk control measures in a way to reduce the risk of drug shortages.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations 40

Regulations FDA Science Production 40

Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative. They’ve created voluntary licensing agreements with six other pharmaceutical manufacturers (Dr.

Clinical Trials 74

Clinical Trials Virus Vaccine DNA 74

Drug & Device Law

JULY 31, 2023

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. Ohio 2006) (“the same reasoning is even more appropriate in this context of broadcast media”). In Gorran v.

Production 52

Production Trials International Government 52

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. 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. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

Testimonials 59

Testimonials Doctors Production Laboratories 59