Search for: "FOOD AND DRUG ADMINISTRATION"
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26 May 2007, 12:25 pm
NPR: 365-Day Birth Control Pill Stirs Controversy:A new birth control pill that eliminates women's monthly periods gained Food and Drug Administration approval this week. [read post]
30 Oct 2009, 11:03 pm
Food and Drug Administration [Friday, Oct. 30] sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations... [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]
29 Nov 2006, 11:27 am
Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women... [read post]
27 Mar 2023, 2:00 am
Brian Miller (Johns Hopkins University), William Blanks (West Virginia University), Brian Yagi (Johns Hopkins University), The 510(K) Third Party Review Program: Promise and Potential (2023): Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing... [read post]
4 Jun 2008, 5:01 pm
The Federal Drug and Food Administration issued in June of 2006 (and later with additional FDA Alerts in December 2006 and May 2007), a warning to Health Care Professionals, concerning Gadolinium Based Contrast Agents (GMCAs), used for Magnetic Resonance Imaging (MRI) and the risk of contracting Nephrogenic Systemic Fibrosis (NSF). [read post]
3 Feb 2014, 11:33 am
FDA Will Investigate Approved Testosterone Therapies for Heart Link The Food and Drug Administration (FDA) issued a statement on Friday, January 31st, that the agency will investigate reported risks for heart attack and stroke associated with testosterone therapy. [read post]
5 Aug 2009, 1:33 pm
Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and... [read post]
17 Mar 2015, 8:29 am
Another Warning from the FDA Chides Doctors for Over-Prescribing and Enabling Overuse of Testosterone Therapy The Food and Drug Administration has issued another warning to doctors regarding overuse of testosterone replacement therapy – the gels, pills, and ointments, the agency says, should not be overused to treat common signs of aging, such as low libido […] [read post]
21 Sep 2023, 10:00 pm
The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits, among other things, unfair methods of competition. [read post]
21 Jan 2022, 2:00 am
Food and Drug Administration (FDA) has not yet used... [read post]
8 Feb 2024, 10:00 pm
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs). [read post]
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]
18 Aug 2008, 2:42 pm
Food and Drug Administration (FDA) announced a Class 1 Recall of Boston Scientific's NexStent Monorail, NexStent Carotid Stent, and Monorail delivery system "because the tip of the stent-delivery system may detach during the procedure. [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]
19 Mar 2010, 9:33 am
[JURIST] The US Food and Drug Administration (FDA) [official website] on Thursday announced [press release] a final rule [text] restricting tobacco sales and promotions directed at youth. [read post]
25 Sep 2015, 9:53 am
CNN: Essure Sterilization Method under Fire, by Elizabeth Cohen: More than 5,000 women have complained to the Food and Drug Administration about Bayer's Essure, a sterilization device, saying it caused problems including unintended pregnancies, stillbirths and debilitating pain and bleeding.... [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]
17 Dec 2020, 2:20 pm
The Food and Drug Administration is expected to follow the recommendation for the vaccine from Moderna and the National Institutes of Health. [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]
