Agency IQ

OCTOBER 20, 2023

Data from the 2012, 2016, and 2020 CDR and 1998, 2002, and 2006 Inventory Update Reporting (IUR) Rule are included in the PFAS Analytic Tools. While there are a variety of reporting thresholds, sites manufacturing or importing 25,000 pounds or more of a chemical substance in a given year are required to report to CDR.

Regulations 40

Regulations Production Packaging Treatment 40

Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

FDA 40

FDA Science Biosimilars Regulations 40

Codon

JUNE 2, 2024

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. Adapted from Yoshiki and Moriwaki (2006). In a testimony in front of the U.S. Origins of mice used in research. Image Credit: JAX Handbook.

Laboratories 117

Laboratories Research Disease Science 117

Drug & Device Law

JANUARY 15, 2024

2d 888 (1996) (manufacturer immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warning). The court refused to apply strict liability, holding “that even if [defendants] could be shown to have ‘marketed’ the prosthesis, strict liability does not apply.” Medtronic, Inc. ,

Compliance 52

Compliance Government FDA Compliance Production 52

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. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That “common and widely known side effect” of many “chemotherapy drugs,” id.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d 3d 75 (Fla.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

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.” to determine whether a proposed alternative drug would have received FDA approval.” 2006), app. 2006), app.

FDA 59

FDA FDA Approval Testimonials Vaccine 59