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7 Aug 2012, 2:09 pm
The Food and Drug Administration has warned that the use of transvaginal mesh exposes patients to a greater risk of complications than other methods of surgical vaginal repair. [read post]
28 Dec 2020, 10:00 pm
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. [read post]
7 Jun 2008, 5:00 pm
Here's an excerpt: The number of Food and Drug Administration warning letters sent to companies dropped by half in the past 10 years,... [read post]
28 Apr 2008, 5:33 am
Food and Drug Administration today [April 23, 2008] issued a final regulation barring certain cattle materials from all animal... [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
24 Mar 2007, 8:13 pm
Food and Drug Administration on March 21, 2007. [read post]
23 Mar 2007, 3:49 pm
The California Department of Health Services and the Food and Drug Administration released their final report on the spinach E. coli outbreak today. [read post]
5 Jan 2009, 6:39 am
Food and Drug Administration, which, in the eyes of... [read post]
9 Sep 2018, 9:00 pm
The US Food and Drug Administration issued a draft guidance document on September 6 stating it will allow use of the colony forming units (CFUs) unit of measure in the Supplement Facts panel. [read post]
28 Dec 2020, 10:00 pm
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. [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]
17 Mar 2009, 1:01 pm
Here's an excerpt: President Barack Obama's choice to lead the Food and Drug Administration faces several crises at the beginning of... [read post]
14 Sep 2023, 10:00 pm
Gucciardo , who counsels medical device manufacturers throughout the product lifecycle in the US Food and Drug Administration (FDA) regulatory context, shares insight into some important considerations when creating, reviewing, and implementing medical device product warranties. [read post]
15 Feb 2022, 10:00 pm
Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. [read post]
27 Aug 2020, 10:00 pm
The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the Food and Drug Administration (FDA) would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. [read post]
19 Feb 2016, 5:00 am
Food and Drug Administration) has the authority over regulating and approving implants. [read post]
25 Apr 2010, 6:54 pm
USA Today (Op-Ed): Female Condom empowers women to save themselves, by Yolanda Young: In 1993, the Food and Drug Administration gave its stamp of approval to a then-novel item: the female condom. [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]
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 2009, 2:14 pm
The US Food and Drug Administration (FDA) is reviewing adverse event information for Exjade from a database that tracks all patients who are prescribed deferasirox (Exjade). [read post]
