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31 Jul 2018, 12:17 pm
For some background and so as to put this Bayer action regarding Essure in perspective, we get this timeline from another item issued July 20, 2018, "Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed": When [the FDA] first became aware of an increase in adverse events submitted to our database concerning [the… [read post]
24 Jul 2018, 4:57 pm
The U.S. [read post]
24 Jul 2018, 4:57 pm
The U.S. [read post]
20 Jul 2018, 1:51 pm
Source: Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed, U.S. [read post]
3 Apr 2018, 3:46 pm
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said FDA Commissioner Scott Gottlieb, M.D. [read post]
19 Mar 2018, 6:39 pm
At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, M.D. [read post]
18 Feb 2018, 4:22 am
Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose,” said FDA Commissioner Scott Gottlieb, M.D. [read post]
8 Jan 2018, 9:00 pm
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (To sign up for a free subscription to Food Safety News, click here.) [read post]
27 Dec 2017, 5:00 am
Balanescu, No. 4:16-CV-00549 (M.D. [read post]
29 Nov 2017, 5:03 am
A number of Congressional panels have scheduled or held recent hearings on health policy issues, including the following: On November 30, 2017, the House Energy & Commerce Committee is holding a hearing on implementation of the 21st Century Cures Act (Cures Act), featuring testimony by National Institutes of Health Director Francis Collins, M.D. and Food and Drug Administration Commissioner Scott Gottlieb, M.D. [read post]
27 Oct 2017, 8:48 am
On October 17, 2017, Congressman Jimmy Panetta (D-CA), Congressman Neal Dunn, M.D. [read post]
2 Oct 2017, 7:19 am
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. [read post]
2 Oct 2017, 6:15 am
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. [read post]
22 May 2017, 11:05 am
., No. 16-1534, M.D. [read post]
19 May 2017, 12:23 pm
See M.D. [read post]
15 May 2017, 1:36 pm
Robinson’s departure last year, the Board’s General Counsel, Scott Freshour, has served as the Interim Executive Director. [read post]
3 May 2017, 12:32 pm
Scott Petroleum, LLC, 809 F.3d 746 (3d Cir. 2016). [read post]
22 Mar 2017, 4:01 am
Scott Peck, M.D. [2] There is a limiting factor that I have omitted because in the context of this post it does not apply once guilt has been established. [read post]
15 Feb 2017, 9:00 pm
In Scott v. [read post]
15 Feb 2017, 8:06 am
., 2016 WL 7135076, No.14–cv–1955 (M.D. [read post]
