If finalized as proposed, FDA would implement a new “phaseout policy” that would, across five stages and within four years, apply the same regulatory requirements applicable to in vitro diagnostics (IVDs) on the majority of clinical laboratories offering tests as LDTs. Once i...
this viewpoint manuscript aims to spotlight the existing diagnostic landscape and unmet clinical needs for 4 emerging NTDs increasingly prevalent in the United States, additionally, it delves into the possible adverse effects of the FDA's Proposed Rule on Laboratory-D...
and that laboratories are likely to dispute. When the FDA started regulating medical devices in 1976, lab-developed tests were simple and offered mostly to local patient populations. The agency generally
After many years of deliberation, FDA has crafted a proposed rule for drug products that present demonstrable difficulties for compounding FDA has proposed a set of six criteria to consider when determining whether a drug product should be included on FDA’s demonstrably difficult-to-compoun...
The FDAreleased its proposed rulefor the oversight of laboratory-developed tests at the beginning of October 2023 and provided a 60-day public comment period through Dec. 4. As of Jan. 18, the agency had collected and posted 6,707 public comments, making themavailable for viewing and...
Collective Movement in the Tibetan Macaques (Macaca thibetana): Early Joiners Write the Rule of the Game Collective behavior has recently attracted a great deal of interest in both natural and social sciences. While the role of leadership has been closely scrutinized, the rules used by joiners ...
Aiming to optimize efficiency in drug development while protecting patient safety, the proposed FDA rule may be beneficial to all key trial stakeholders, including sponsors, site teams and ultimately, patients. Let’s take a closer look at what the real-
information on the safe and effective use of these new animal drugs. The FDA is accepting public comments on the proposed rule for 90 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the proposed rule by June 10, ...
WASHINGTON, D.C. – Today, the U.S. Food and Drug Administration (FDA) released a proposed rule on front-of-package (FOP) nutrition labels, that would mandate a nutrition information box on the front of food packages to complement the existing required Nutrition Facts label. The pr...
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning St... The Food and Drug Administration (FDA) is proposing ...