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11 Jan 2015, 2:00 pm
Food and Drug Administration (FDA) to investigate an outbreak of Listeria monocytogenes infections (listeriosis) linked to commercially produced, prepackaged caramel apples. [read post]
4 Mar 2011, 1:59 am
Food and Drug AdministrationDavid Heymann, Head and Senior Fellow, Centre on Global Health Security, Chatham House, United KingdomPaul B. [read post]
9 Jun 2023, 2:24 pm
Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity and Modernization mandates established by Congress under the Food and Drug Omnibus Reform Act of 2022 (FDORA), including developments on the intersection and use of digital health technology in clinical trials and clinical trial diversity. [read post]
23 May 2011, 9:12 pm
FDA to Pull Diabetes Drug Avandia from Pharmacy Shelves, US News, May 19, 2011 FDA puts heavy restrictions on Avandia, McKnights's, May 20, 2011 Related Web Resources: Food and Drug Administration Avandia, NIH Glaxo Smith Kline More Blog Posts: Boston Personal Injury? [read post]
20 Jun 2013, 6:14 am
On June 12, 2103 the Food and Drug Administration (FDA) published a final rule amending the orphan drug regulations (21 CFR Part 316). [read post]
14 Oct 2021, 6:24 am
Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act. [read post]
28 Oct 2010, 3:43 am
The CBS Evening News reported, “Glaxo-Smith-Kline agreed to pay $750 million to settle a case involving defective drugs, including the anti-depressant Paxil [paroxetine]. [read post]
28 Dec 2014, 10:02 pm
Smith that an investigation of his operation on Oct. 14 and 16, 2014, revealed violations of the FD&C Act. [read post]
29 May 2019, 1:30 pm
Smith & Nephew contends that it is immune from liability for any alleged defects in the design of its BHR products on the basis that the Food & Drug Administration approved the product through a Premarket Approval application, commonly known as the “PMA” process (which is a more rigorous review process by the FDA than is often used for other hip implant products). [read post]
17 Aug 2022, 10:41 am
Food and Drug Administration (FDA), and the U.S. [read post]
7 Oct 2013, 8:34 am
House of Representatives will vote today on a bill that would fund the Food and Drug Administration during the government shutdown. [read post]
30 Sep 2013, 2:26 pm
Department of Health and Human Services states that, in the absence of appropriations, 45 percent of the Food and Drug Administration’s 14,779 employees would be temporarily forced out of their jobs. [read post]
12 Jan 2009, 2:44 pm
The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the public reporting requirements for “applicable clinical trials” involving certain drugs, biologicals, and devices. [read post]
14 Feb 2011, 1:59 am
Editor's note: This is the third in a series of articles from CSPI Food Safety Director Caroline Smith DeWaal on the implementation of the FDA Food Safety Modernization Act. [read post]
25 Dec 2010, 1:59 am
Food and Drug Administration has not yet issued a report for the second half of the year, but there is enough evidence that the FDA's Reportable Food Registry is a success.New tools in the war against foodborne illness don't occur that often, and there has been plenty of skepticism about how FDA would implement a congressional mandate for an electronic portal for the industry and public health officials to use when they know something might harm the human or… [read post]
27 Dec 2011, 1:59 am
Food and Drug Administration (FDA) was 2011's 5th most important food safety story.The case was notable for several reasons. [read post]
8 Jan 2015, 9:11 am
The Canadian Food Inspection Agency is working with its federal partners, the Public Health Agency of Canada and Health Canada, and the United States Food and Drug Administration and is conducting a food safety investigation, which may lead to the recall of other products. [read post]
16 Jul 2018, 3:02 am
Upsher-Smith Laboratories, Inc., No. 2:16-cv-02604 (6th Cir. [read post]
15 May 2013, 10:46 am
Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited Guangzhou Pharma Case Fosun Pharma to Acquire Israel-Based Medical Device Manufacturer Beijing Hosts Traditional Chinese Medicine ("TCM") Training Program Ministry of Industry and Information Technology ("MIIT") Supports Development of Medical Devices Changes in the Healthcare Industry Medical Reforms in China Attract Pharma Giants State Council Issues Guiding Opinions on the… [read post]
29 Sep 2022, 9:06 pm
” In closing, Marler’s advice to the panel was to create separate commissioners in the FDA — one for food and one for drugs. [read post]
