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28 Apr 2024, 11:33 am
A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts. [read post]
25 Apr 2024, 9:46 am
United States ex rel. [read post]
23 Apr 2024, 9:01 pm
The United States requested clarification on whether a certificate issued by the Food and Drug Administration (FDA) to foreign governments for products covered by the notice would be acceptable. [read post]
21 Apr 2024, 9:05 pm
Food and Drug Administration has announced a priority review of the first psychedelic new drug indication—MDMA-assisted therapy for PTSD. [read post]
18 Apr 2024, 9:05 pm
Food and Drug Administration does not currently have concerns about the safety or availability of pasteurized milk products nationwide. [read post]
16 Apr 2024, 9:04 pm
The new approach by the Food and Drug Administration is designed to provide post-incident response action. [read post]
16 Apr 2024, 8:42 am
Regeneron Pharmaceuticals and Ocular Therapeutix teamed up to file their own amici curiae brief in support of Salix, in which they attributed the increasing use of clinical trial protocol summary disclosures as evidence of a “reasonable expectation of success” in the obviousness analysis to the enactment in 2007 of the Food and Drug Administration Amendments Act, which greatly expanded the number of trials requiring disclosure, which was exacerbated by… [read post]
14 Apr 2024, 9:05 pm
Drug Enforcement Administration. [read post]
12 Apr 2024, 9:03 pm
The Food and Drug Administration imposes regulations concerning major food allergens and gluten-free labeling to safeguard the wellbeing of individuals with allergies and celiac disease, respectively, ensuring food safety. [read post]
10 Apr 2024, 9:06 pm
The Food and Drug Administration (FDA) confirmed the elevated lead levels in the recalled applesauce, with FDA officials suspecting intentional contamination. [read post]
10 Apr 2024, 5:08 pm
The case is captioned United States ex rel. [read post]
8 Apr 2024, 10:00 pm
Read now » Related Content FDA Warning Letters Tracker Monitor trends in Food and Drug Administration (FDA) enforcement activity, including warning letters issued for alleged violations of product labeling requirements. [read post]
8 Apr 2024, 1:33 pm
While an infected hen could pass the virus to an egg, the chance of being exposed to bird flu through eggs bought from the grocery store is also incredibly low, according to the Food and Drug Administration (FDA). [read post]
8 Apr 2024, 10:08 am
In December 1996, Judge Jones issued his decision that excluded the plaintiffs’ expert witnesses’ proposed testimony on grounds that it failed to satisfy the requirements of Rule 702.[5] In October 1996, while Judge Jones was studying the record, and writing his opinion in the Hall case, Judge Weinstein, with a judge from the Southern District of New York, and another from New York state trial court, conducted a two-week Rule 702 hearing, in Brooklyn. [read post]
2 Apr 2024, 12:56 pm
Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, “estimated that as much as 75 per cent of published biomarker associations are not replicable. [read post]
2 Apr 2024, 9:13 am
The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. [read post]
1 Apr 2024, 9:05 pm
CDC works closely with state and federal agencies, including USDA, the Food and Drug Administration (FDA), and local health authorities to further investigate and closely monitor this situation. [read post]
31 Mar 2024, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
29 Mar 2024, 9:54 am
Food and Drug Administration’s (“FDA”) regulatory review framework for infant formula products. [read post]
28 Mar 2024, 9:05 pm
Food and Drug Administration has approved Winrevair, a medication designed to address high blood pressure in adults caused by lung artery constriction—a condition known as pulmonary arterial hypertension (PAH). [read post]
