Remove 2006 Remove Testimonials Remove Treatment Remove Trials
article thumbnail

Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. Testimonials are not necessarily representative of all of those who will use our products. A survey of the opinions of obesity experts on the causes and treatment of obesity.

Disease 52
article thumbnail

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Origins of the Lab Mouse

Codon

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. The majority of lab animals (about 95 percent) are mice or rats.

article thumbnail

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the evidence. In my view, the complicated legal issue presented in this appeal is unfortunately not resolvable because of the undeveloped evidentiary record and undirected advocacy in the trial court. Medtronic, Inc. ,

article thumbnail

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Drug & Device Law

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

article thumbnail

The FDA and Feasible Alternative Designs

Drug & Device Law

2006), app. Because mesh such as [plaintiff’s claimed alternatives] were not cleared by the FDA for treatment of stress [plaintiff’s condition] at the time of [her] surgery, they were not legally available at the time and, in this Court’s view, they do not qualify as safer alternative designs as a matter of law. 2d 839, 851 (N.Y.

FDA 59
article thumbnail

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. caused anything.