Search for: "FOOD AND DRUG ADMINISTRATION"
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12 Jan 2007, 10:11 am
From the press release: The Food and Drug Administration (FDA)... [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]
10 Nov 2021, 10:00 pm
The US Food and Drug Administration recently issued an order authorizing R.J. [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]
1 Dec 2020, 12:30 pm
Food and Drug Administration’s (FDA) draft guidance... [read post]
13 Feb 2019, 1:24 am
The Food and Drug Administration (FDA) recent approval of an Emergency Use Authorization (EUA) (the “Authorization”) for an in vitro diagnostic device for detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) reminds Americans and their health care organizations the Ebola virus outbreak in the Democratic Republic of the Congo […] [read post]
8 Jun 2008, 6:26 pm
FDA news release: The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw,... [read post]
29 Oct 2019, 9:42 pm
In a blow to the image of safety and uprightness that Johnson & Johnson attempts to present to the world, a report from the Food and Drug Administration indicated that traces of asbestos were discovered in a bottle of baby powder only 13 days after the corporation’s CEO, Alex Gorsky, publicly declared his firm and […] [read post]
1 Nov 2017, 7:39 am
In September 2017, the Food and Drug Administration wrote a letter to Pfizer, the maker of the EpiPen, stating that the company had failed to investigate claims of defective units.... [read post]
HHS Overrules FDA Decision to Allow Younger Teens Access to Emergency Contraceptive Over the Counter
6 Dec 2011, 9:25 pm
The New York Times: Plan to Widen Availability of Morning-After Pill Is Rejected, by Gardiner Harris: For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives... [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]
22 Sep 2015, 10:56 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]
21 Apr 2013, 9:19 pm
, by Elizabeth Rosenthal: WHEN a federal judge recently ordered the Food and Drug Administration to make the morning-after pill available to women of all ages without a prescription, the... [read post]
30 Dec 2021, 9:00 am
The Food and Drug Administration (FDA) receives more than 100,000 reports annually related to medication errors. [read post]
11 Sep 2008, 7:36 pm
Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her... [read post]
5 Aug 2024, 10:00 pm
In this piece published by HBW Insight , partner Rachel Raphael and co-author Marcha Isabelle Chaudry, Esq. of The Equity and Wellness Collaborative encourage cosmetics companies to familiarize themselves with current good manufacturing practices standards and offer tips on building out their quality programs ahead of US Food and Drug Administration rulemaking. [read post]
5 Aug 2024, 10:00 pm
In this piece published by HBW Insight , partner Rachel Raphael and co-author Marcha Isabelle Chaudry, Esq. of The Equity and Wellness Collaborative encourage cosmetics companies to familiarize themselves with current good manufacturing practices standards and offer tips on building out their quality programs ahead of US Food and Drug Administration rulemaking. [read post]
5 Aug 2024, 10:00 pm
In this piece published by HBW Insight , partner Rachel Raphael and co-author Marcha Isabelle Chaudry, Esq. of The Equity and Wellness Collaborative encourage cosmetics companies to familiarize themselves with current good manufacturing practices standards and offer tips on building out their quality programs ahead of US Food and Drug Administration rulemaking. [read post]
5 Aug 2024, 10:00 pm
In this piece published by HBW Insight , partner Rachel Raphael and co-author Marcha Isabelle Chaudry, Esq. of The Equity and Wellness Collaborative encourage cosmetics companies to familiarize themselves with current good manufacturing practices standards and offer tips on building out their quality programs ahead of US Food and Drug Administration rulemaking. [read post]
5 Aug 2024, 10:00 pm
In this piece published by HBW Insight , partner Rachel Raphael and co-author Marcha Isabelle Chaudry, Esq. of The Equity and Wellness Collaborative encourage cosmetics companies to familiarize themselves with current good manufacturing practices standards and offer tips on building out their quality programs ahead of US Food and Drug Administration rulemaking. [read post]
