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20 Feb 2023, 10:00 pm
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. [read post]
12 Aug 2014, 12:59 pm
On August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titled “Biosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval”. [read post]
29 Dec 2020, 10:00 pm
Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent 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]
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]
4 Mar 2008, 4:33 am
[JURIST] A federal judge Tuesday dismissed [opinion, PDF] a lawsuit brought by the Association of American Physicians and Surgeons (AAPS) [group website] against the US Food and Drug Administration (FDA) [official website] and Barr Pharmaceuticals [corporate website] seeking to overturn the FDA's 2006 decision to approve the over-the-counter sale [JURIST report] of so-called "morning after" Plan [read post]
24 Sep 2020, 4:15 am
Food and Drug Administration (FDA) and the biopharmaceutical industry. [read post]
24 Sep 2014, 6:27 am
Despite Possible Spread of Cancer, Gynecologists Urge FDA to Reconsider Stance on Power Morcellators In April of this year, the Food and Drug Administration issued a warning about power morcellators, which until very recently were widely used by gynecological surgeons to remove uterine fibroids (which can cause painful menstrual periods) or for partial or full […] [read post]
23 Feb 2018, 1:51 pm
On Wednesday, The Food and Drug Administration (F.D.A) took a massive step towards safety as they approved a new blood test that can detect concussions in people and can quickly identify those with potential brain damage. [read post]
20 Feb 2023, 10:00 pm
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. [read post]
17 Aug 2011, 7:23 am
The suit, filed against the Food and Drug Administration (FDA) [official website] in the US District Court for the District of Columbia [official website], seeks an injunction against the new regulations, which the companies claim unconstitutionally force them to disseminate the government's anti-smoking message. [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]
20 Feb 2023, 10:00 pm
The US Food and Drug Administration (FDA) recently published a final guidance pertaining to quality considerations for clinical research involving cannabis and cannabis-derived compounds,” which adds minor updates to a 2020 draft guidance. [read post]
23 Dec 2011, 1:45 pm
The AM Law Daily, December 7, 2011 by Sara Randazzo http://amlawdaily.typepad.com/amlawdaily/2011/12/hughes-hubbard-opens-in-kansas-city.html With the Food and Drug Administration turning up the heat on tobacco makers in recent years, industry rivals are increasingly at odds over how far regulators should go, says Stephen Sugarman. [read post]
9 Aug 2023, 10:00 pm
The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). [read post]
26 Feb 2024, 9:00 am
Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. [read post]
27 Jan 2021, 10:00 pm
The Food and Drug Administration (FDA) issued a press release on January 26 announcing a countrywide import alert on all alcohol-based hand sanitizers manufactured in Mexico due to their potential methanol content. [read post]
25 Apr 2022, 9:15 am
Food & Drug Administration’s user fee program can better advance innovation in medical products. [read post]
11 Aug 2015, 7:23 am
The Tampa Bay (FL) Times reported that the e-cigarette industry is “watching closely” as the Food and Drug Administration “is considering a slate of new regulations that could put smaller liquid nicotine distributors out of business. [read post]
25 Mar 2020, 4:15 am
The Sanofi decision provides a possible opportunity to seek antitrust liability against brand companies for abusing Food and Drug Administration (FDA) regulations. [read post]
2 Apr 2022, 1:54 pm
Food and Drug Administration (FDA) has called out Philips Respironics for its inadequate efforts in notifying patients, suppliers, and healthcare providers of a massive recall of some of the company’s breathing assistance devices. [read post]
