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16 Jun 2023, 5:51 pm
The Food and Drug Administration has issued an alert advising consumers and pharmacies to immediately stop using and selling specific lots of the over-the-counter children’s cough suppressant. [read post]
15 Feb 2011, 12:30 pm
The federal Food and Drug Administration issued an alert last week notifying consumers and medical professional of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy. [read post]
24 Oct 2023, 10:00 pm
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific information on unapproved uses of approved/cleared (collectively referred to as “approved”) medical products. [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The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization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]
19 Oct 2022, 10:00 pm
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). [read post]
1 Dec 2011, 6:29 am
[JURIST] The Food and Drug Administration (FDA) [official website] on Tuesday filed notice that it intends to appeal [text, PDF] an injunction that blocked new graphic warning labels on cigarette packages. [read post]
4 Feb 2009, 6:40 am
These latest recalls come as President Obama promises a review of the Food and Drug Administration. [read post]
11 May 2007, 4:00 am
The settlement resolves allegations that Medicis promoted the use of a topical skin preparation, Loprox, for use on children under the age of 10, without approval by the Food & Drug Administration (FDA). [read post]
23 Feb 2022, 10:00 pm
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. [read post]
14 Jun 2019, 8:27 am
Backers of Maryland’s stem cell ecosystem hope a federal judge’s ruling last week in a Flordia case that the Food and Drug Administration can regulate stem cell treatments is the first step toward protecting their legitimacy. [read post]
27 Mar 2016, 6:30 am
An emergency approval has been granted by the Food and Drug Administration for a new three-in-one laboratory test for Zika and a pair of other dangerous viruses, according to the Center for Disease Control and Prevention. [read post]
27 May 2014, 8:14 am
In April, the Food and Drug Administration (FDA), announced that it […] [read post]
4 Jun 2013, 10:36 am
A study in March by the National Toxicology Program found that the popular dietary supplement gingko biloba caused cancer in lab animals, and, as a result, the Center for Science in the Public Interest is urging the Food and Drug Administration to ban iRead more: http://www.nydailynews.com/news/national/cancer-fears-lead-group-call-gingko-ban-article-1.1362149#ixzz2VGnZmWiO [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]
11 Jan 2024, 10:00 pm
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. [read post]
2 Aug 2021, 10:00 pm
Food and Drug Administration. [read post]
30 Oct 2008, 5:02 pm
Times report on the Food and Drug Administration staff’s opposition to preemption. [read post]
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]
28 Dec 2015, 12:00 am
Food and Drug Administration receives hundreds of thousands of serious complaints about defective medical devices every year. [read post]
17 Apr 2018, 1:42 pm
The mdPACE program helps medical device startups navigate the federal regulatory approval process, with a particular focus on the Food and Drug Administration’s 510(k) approval. [read post]
