Posts tagged with: "fda"
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18 Dec 2015, 12:00 am
FDA’s AquaAdvantage approvalUnderstand the law, evaluate the politics of policy changeBy Michaela OldfieldSeveral weeks ago, the FDA released its approval of AquaAdvantage salmon. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
26 Jul 2020, 10:00 pm
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date. [read post]
24 Oct 2018, 1:45 pm
The OIG specifically provided three recommendations for the FDA: Promote the use of the FDA’s pre-submission program (Pre-Sub Program) to discuss cybersecurity concerns Include cybersecurity documentation as a criterion in the FDA’s current Refuse To Accept checklists Revise its “Smart” template to prompt FDA reviewers with specific cybersecurity questions The FDA has voiced its agreement with all three of the recommendations and… [read post]
8 Mar 2008, 12:14 am
The defendants sought and received FDA approval to market generic equivalent Polyethylene Glycol 3350, using the Accelerated New Drug Approval (ANDA) process to piggyback on Schering-Plough's approval. [read post]
22 Aug 2018, 9:00 am
What are FDA Warning Letters? [read post]
22 Aug 2018, 9:00 am
What are FDA Warning Letters? [read post]
3 Jun 2013, 11:51 am
A half century ago, FDA treated consumers as passive and ignorant. [read post]
28 Jul 2017, 8:56 am
The FDA has not yet set a new deadline for label compliance. [read post]
28 Jul 2017, 8:56 am
The FDA has not yet set a new deadline for label compliance. [read post]
12 Aug 2015, 9:18 am
FDA, No. 15 Civ. 35888, 2015 WL 4720039, 2015 U.S. [read post]
16 Jan 2014, 7:48 am
Levinemakes “discussions and negotiations” with the FDA not only relevant, but also potentially dispositive if those interactions show that the FDA would have rejected the plaintiffs’ proposed warning. [read post]
11 Oct 2021, 10:44 am
Medtronic expands its FDA insulin pump recall. [read post]
20 Sep 2013, 4:42 pm
For over-the-counter Tylenol and its generic equivalents, the FDA requires no warning that overdose can be fatal.http://www.propublica.org/getinvolved/item/should-fda-require-all-acetaminophen-drugs-carry-black-box-warnings [read post]
8 Jun 2016, 11:21 am
The study shows FDA used flawed data to approve devices, including Essure.The post Study Shows FDA Used Flawed Data to Approve Devices appeared first on Legal Reader. [read post]
5 Mar 2024, 9:00 am
What do the data show regarding FDA’s performance in moving proposed guidance to final? [read post]
