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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]
2 Apr 2024, 4:00 am
The Food and Drug Administration is assuring everyone that it has stockpiles of vaccine for highly pathogenic avian influenza A [i.e., A(HPAI)]. [read post]
29 Apr 2008, 5:18 am
New Documents on NACUA.WEB: FDA: Human Subject Protection--Foreign Clinical Studies Complete text (17 pages) of Final Rule issued by the Food and Drug Administration and published in the April 28 Federal Register. [read post]
5 Jul 2020, 10:00 pm
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight, product liability, and digital health/telehealth regulation. [read post]
20 Jul 2020, 10:00 pm
The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and life-supporting/life-sustaining devices. [read post]
31 Aug 2023, 2:00 am
FDA, a group of plaintiffs sued the Food & Drug Administration... [read post]
23 Mar 2009, 8:04 pm
NY Times: Plan B Must Be Made Available to 17-Year-Olds, by Natasha Singer: A federal judge on Monday ordered the Food and Drug Administration to make the Plan B morning-after birth control pill available without prescription to women as young... [read post]
12 Apr 2009, 6:17 pm
From the Wall Street Journal online (author Keith J Winstein): The Food and Drug Administration asked several medical-device makers to justify their products' safety and effectiveness, as part of a move to require tougher evidence standards before products can be... [read post]
10 Nov 2021, 10:00 pm
The US Food and Drug Administration recently issued an order authorizing R.J. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [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]
22 Jun 2009, 7:09 pm
Here's an excerpt: President Obama signed landmark legislation Monday giving the Food and Drug Administration new power to regulate the manufacturing, marketing and sale of tobacco. [read post]
20 Feb 2015, 1:28 pm
The Food and Drug Administration has approved a new technique for treating varicose veins by sealing them with a clear liquid that turns into a solid adhesive. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [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]
28 Mar 2008, 4:34 pm
Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total... [read post]
10 Nov 2021, 10:00 pm
The US Food and Drug Administration recently issued an order authorizing R.J. [read post]
31 Oct 2016, 7:51 am
As of August, 2016, the Food and Drug Administration (FDA) now has the authority to regulate ENDS, or Electronic Nicotine Delivery Systems. [read post]
29 Oct 2014, 1:44 pm
The Food and Drug Administration says it cleared Pfizer’s Trumenba to prevent a subtype of Meningococcal disease in people ages 10 to 25. [read post]
