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23 Oct 2012, 7:44 am
Food and Drug Administration (FDA) approval process. [read post]
26 Oct 2023, 10:00 pm
Partners Jacqueline Berman and Maarika Kimbrell wrote an article for Law360 summarizing draft guidance from the US Food and Drug Administration that revises its approach to the dissemination of scientific information on unapproved uses (SIUU) of approved or cleared medical products. [read post]
18 Dec 2014, 8:03 pm
According the WSJ: "The Food and Drug Administration used its authority to call for an immediate [read post]
9 Feb 2021, 2:00 am
Food and Drug Administration (FDA) plays a vital role in... [read post]
5 Oct 2021, 2:00 am
Food and Drug Administration (FDA) Commissioner Scott Gottlieb decreed interchangeable insulin poised for market entry within the next few years. [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
18 Oct 2008, 8:19 am
In the Hatch-Waxman area, Pozen, Inc. announced Par Pharmaceutical Inc. has filed an application with the Food and Drug Administration [FDA] to make a generic version of Treximet, a migraine treatment Pozen developed with GlaxoSmithKline PLC, and shares of Pozen shed nearly 28 percent of their value on 17 Oct. 08 [read post]
5 Apr 2013, 7:39 am
Federal District Court Judge Korman of the New York Eastern District (covering Brooklyn and Long Island) issued a ruling yesterday (here) ordering the Food and Drug Administration to make the Plan B or the “Morning After” available over-the-counter to women of all ages. [read post]
29 Sep 2009, 6:10 am
Today, September 29 December 28 is the deadline for submitting comments to the Food and Drug Administration on (FDA's docket) implementing the Family Smoking Prevention and Tobacco Control Act. [read post]
10 Nov 2021, 10:00 pm
The US Food and Drug Administration recently issued an order authorizing R.J. [read post]
21 Sep 2023, 10:00 pm
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition. [read post]
25 Sep 2015, 7:41 am
., Board Certified by The Florida Bar in Health Law In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration … Continue reading → [read post]
6 Jun 2022, 7:56 am
The abstract provides: The recent Food and Drug Administration (FDA) marketing authorizations granted for testing mutations associated with hereditary... [read post]
28 Feb 2008, 5:12 am
"Too confident in the FDA": The Boston Globe today contains an editorial that begins, "Last week, the US Supreme Court ruled that patients injured by defective medical devices have no right to sue for damages if the devices were approved by the Food and Drug Administration. [read post]
20 May 2004, 3:42 pm
Legislators agreed Thursday on a plan that could lead to greater restrictions on the tobacco industry by giving the authority to regulate the industry to the Food and Drug Administration. [read post]
4 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements. [read post]
27 Jun 2007, 1:03 pm
Food and Drug Administration (FDA) has issued a final rule for current good manufacturing processes (CGMPs) for dietary supplements. [read post]
16 Nov 2017, 9:00 pm
On November 15, the US Food and Drug Administration (FDA) published a draft guidance on best practices to help parties interested in convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use. [read post]
16 Jan 2008, 6:06 am
Food and Drug Administration announced today that meat from cloned animals... [read post]
27 Jun 2009, 5:00 am
Food and Drug Administration on Wednesday approved a generic version of the controversial Plan B morning-after contraceptive. [read post]
