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19 Aug 2014, 9:41 am
This post was written by Jennifer Pike and Vicki Morris On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under GDUFA as set forth in the GDUFA Commitment Letter accompanying the legislation. [read post]
2 Jul 2009, 4:55 am
Food and Drug Administration today that it was withdrawing Accutane after a "reevaluation" of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement. [read post]
11 Apr 2024, 9:05 pm
Frank Yiannas, the former deputy commissioner of food policy and response at the Food and Drug Administration, recently gave Food Safety News insights into Rule 204 of the Food Modernization Act. [read post]
16 Sep 2013, 8:00 am
Food and Drug Administration issued notice of a webinar it will host in October to comply with an executive order mandating consultation with American Indian tribes. [read post]
12 Nov 2013, 10:02 pm
Food and Drug Administration’s Produce Safety Rule is Nov. 15, 2013. [read post]
31 Jul 2013, 8:04 pm
Food and Drug Administration (FDA) did not approve it as safe and effective, the Justice Department announced the other day. [read post]
14 Mar 2022, 9:03 pm
Food and Drug Administration has issued guidance on its intent not to enforce certain provisions of five rules that implement the Food Safety Modernization Act. [read post]
27 May 2010, 6:51 am
The Quincy Patriot-Ledger recently reported that the Food and Drug Administration issued a second warning to Braintree Laboratories about its manufacturing processes. [read post]
24 Jan 2024, 5:00 am
The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently released a joint statement suggesting that the FDA is about to end its decades-long policy of declining to regulate lab-developed tests (LDTs). [read post]
18 Jun 2012, 2:52 am
After a series of press reports about internal scientific disagreements at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regarding certain medical device approvals, in October 2009 CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions. [read post]
18 Jun 2012, 2:52 am
After a series of press reports about internal scientific disagreements at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) regarding certain medical device approvals, in October 2009 CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions. [read post]
17 Mar 2009, 9:09 pm
Food and Drug Administration ("FDA") expansion of the Peanut Corporation of America’s (PCA) Salmonella related recall to include all peanut ingredient products produced in PCA’s Plainview, Texas facility since January 1, 2007. [read post]
14 Jun 2011, 5:52 am
In 2000, when the Food and Drug Administration approved it to treat AndroGel hypogonadism, the company announced that the “market was ‘four to five million American men. [read post]
31 Oct 2011, 2:59 am
Food and Drug Administration (FDA) began clearing irradiated foods for sale in 1963, few such foods have attained much prevalence within grocery store aisles. [read post]
26 Jul 2017, 9:01 pm
Food and Drug Administration came out with non-binding guidance “to help growers, manufacturers and food service operators reduce acrylamide levels in certain foods. [read post]
11 Dec 2023, 12:04 pm
The legislation is aimed at helping alleviate worker shortages at such facilities. ( BRIDGE MICHIGAN , LEXISNEXIS STATE NET) FDA Approves First CRISPR-Based Medicine The Food and Drug Administration approved the world’s first medicine based on CRISPR gene-editing technology. [read post]
1 May 2015, 3:59 pm
**Food and Drug Administration Moves on Kind Bars to Force Them to Remove “Healthy” Labels** . . . [read post]
12 Nov 2015, 3:20 pm
A specific problem for defendants is the inability to rely on any definitive Food and Drug Administration (FDA) guidance. [read post]
25 Apr 2023, 9:04 pm
Food & Drug Administration. [read post]
25 Feb 2010, 2:18 pm
Food and Drug Administration requires that companies file field alerts to quickly identify drugs that pose potential safety threats from problems such as contamination or mislabeling. [read post]
