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17 Apr 2023, 10:00 pm
They cover how although the Fifth Circuit recently stayed a Texas federal court's ruling that invalidated the US Food and Drug Administration's (FDA) approval of a commonly used abortion medication, several points made by the courts are worth considering for their potential effect on FDA authority and the challenges they may create for the life sciences industry. [read post]
8 Jul 2016, 7:51 am
The Food and Drug Administration classified the recall as a Class I recall. [read post]
19 Jul 2005, 2:22 am
[JURIST] The Senate on Monday confirmed Lester Crawford [official profile] as the new head of the US Food and Drug Administration [official site] by a 78-16 vote [roll call], ending an earlier debate [JURIST report] about his nomination stalled by legislators' concerns. [read post]
13 Apr 2023, 10:00 pm
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still seriously hinder FDA’s authority with respect to how it regulates products and determines how and when it will interact with the life sciences industry—and the judicial process. [read post]
20 Jun 2024, 10:00 pm
Last year, the US Food and Drug Administration (FDA) announced that it would delay enforcement of certain requirements under the Modernization of Cosmetics Regulation Act (MoCRA) until July 1, 2024 to give the industry more time to comply with pending deadlines. [read post]
5 Jun 2016, 11:43 am
Well according to the Food and Drug Administration, it seems it may be. [read post]
4 Jan 2024, 10:00 pm
The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration (FDA), recently issued a policy statement describing how the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits “unfair methods of competition. [read post]
14 Sep 2023, 10:00 pm
After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
27 Jun 2011, 5:04 pm
The Food and Drug Administration is warning consumers not to eat Evergreen Produce brand alfalfa sprouts or spicy sprouts because they may be linked to 20 cases of salmonella poisoning. [read post]
22 Jun 2012, 11:23 am
Bloomberg News (6/22, Edney) reports that according to a report from the Food and Drug Administration, "almost 16,800 adverse events associated with metal-on-metal hip implants were reported in the US from 2000-2011. [read post]
13 Sep 2008, 12:34 pm
The Food and Drug Administration said that while domestic baby formulas are safe, some Chinese formulas may have entered the country illegally. [read post]
10 Oct 2022, 4:31 pm
Many Tik Tok users have participated in this challenge, which has prompted the Food and Drug Administration to issue a warning stating that cooking chicken in Nyquil is dangerous and could have deadly consequences. [read post]
23 Mar 2012, 1:05 pm
[JURIST] The US District Court for the Southern District of New York [official website] issued an order [text, PDF] to the Food and Drug Administration (FDA) [official website] on Thursday requiring the agency to initiate withdrawal proceedings that could lead to the removal of broad spectrum antibiotics from agricultural livestock feed. [read post]
14 Feb 2008, 7:06 am
Food and Drug Administration (FDA) on February 1, 2008, issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. [read post]
26 Mar 2020, 8:53 am
Food and Drug Administration ... [read post]
2 Mar 2023, 10:00 pm
Partners Michele Buenafe, Jacob Harper, and Andrew Gray wrote the first of a two-part article series for Med Device Online, covering the existing US Food and Drug Administration (FDA) programs, recently issued guidance impacting artificial intelligence and machine learning technologies intended for use in healthcare, and what to expect from the FDA’s FY 2023 priority list. [read post]
13 Apr 2023, 10:00 pm
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still seriously hinder FDA’s authority with respect to how it regulates products and determines how and when it will interact with the life sciences industry—and the judicial process. [read post]
24 Mar 2009, 12:57 am
[JURIST] A judge for the US District Court for the Eastern District of New York [official website] overturned [memorandum and order, PDF] Monday a US Food and Drug Administration (FDA) [official website] decision to limit the over-the-counter (OTC) availability of the Plan B emergency contraceptive pill [product backgrounder] to women over the age of 18. [read post]
29 Jan 2022, 1:03 pm
The Food and Drug Administration has issued a warning about the potential health risks associated with Zantac. [read post]
