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19 Nov 2019, 1:03 pm
Researchers at the Rockville-based Institute for Bioscience and Biotechnology Research (IBBR) received two awards totaling $1.1 million from the Food and Drug Administration and the National Institute for Innovation in Manufacturing Biopharmaceuticals to advance the development of analytical methods for characterizing complex drugs and vaccines. [read post]
16 Jun 2020, 2:15 pm
On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt of public comments regarding the types of patent information published in the FDA’s Orange Book, a collection of FDA-approved drugs and their therapeutic equivalents designed to improve competition from generic drugmakers. [read post]
12 Apr 2017, 10:15 am
Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. [read post]
1 Mar 2013, 12:55 pm
The Food and Drug Administration has announced that drugs that contain calcitonin salmon may increase the potential for cancer in patients. [read post]
8 May 2017, 10:35 am
Food and Drug Administration (FDA) declined in 2016 for the first time in three years. [read post]
24 Aug 2006, 10:50 am
[JURIST] The US Food and Drug Administration (FDA) [official website] on Thursday approved the over-the-counter sale [press release] of the "morning after" or Plan B emergency contraceptive pill [product backgrounder], to women 18 and over. [read post]
2 Sep 2016, 2:15 am
Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). [read post]
5 Apr 2022, 4:15 am
On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. [read post]
29 Feb 2008, 12:33 pm
Food and Drug Administration said the number of deaths possibly associated with the drug heparin, made from pig intestines, had risen to 21 from 4. [read post]
18 May 2012, 5:30 pm
Abbott Laboratories Inc.will pay $1.5 billion to resolve its criminal and civil liability after pleading guilty to federal charges it unlawfully promoted the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration. [read post]
2 Jul 2013, 9:11 am
If this post doesn’t spell out how truly incompetent the Food and Drug Administration is, nothing will. [read post]
9 Jun 2007, 9:24 am
From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News: Top Stories More Questions Surface About FDA's Response To Avandia Risks The House Oversight and Government Reform Committee held a hearing June 6 to probe the Food and Drug Administration's (FDA's) role in evaluating the safety of the diabetes drug Avandia. [read post]
12 Apr 2010, 6:23 am
Data on intravenous dosing and a once-weekly version of Byetta “seem to give a similar signal” as cancers seen in rodent studies of Novo Nordisk A/S’s competing Victoza, said Curtis Rosebraugh, head of the Food and Drug Administration’s Office of Drug Evaluation II, in a Jan. 25 memo posted on the agency’s Web site. [read post]
16 Oct 2015, 7:43 am
[JURIST] The Superior Court of Maricopa County [official website] on Thursday struck down a 2012 Arizona law that mandated abortion pills be regulated according to the Food and Drug Administration (FDA) [official website] as violating the state constitution. [read post]
22 Jul 2011, 8:40 am
The law restricts the use of mifepristone, misoprostol [FDA backgrounders] and other drugs approved by the Food and Drug Administration (FDA) [official website] to induce first-trimester abortions. [read post]
19 Jul 2011, 9:14 am
The law restricts the use of mifepristone, misoprostol [FDA backgrounders] and other drugs approved by the Food and Drug Administration (FDA) [official website] to induce first-trimester abortions. [read post]
Contradictory FDA/USPTO Regulatory Requirements? Belcher’s Missteps Results in Loss of Patent Rights
25 Oct 2021, 6:00 am
Introducing a new drug or medical device to the market introduces additional regulatory hurdles before both the Food and Drug Administration (FDA) and the US Patent and Trademark Office (USPTO). [read post]
5 Apr 2017, 1:05 pm
Food and Drug Administration, said Scott Gottlieb, President Donald Trump’s pick to lead the agency. [read post]
28 Sep 2006, 11:20 am
The law was modeled after a regulation issued by the Food and Drug Administration (FDA) [official website] six years ago that warned against administering the drug after the seventh week of a woman's pregnancy [read post]
9 Apr 2014, 1:25 pm
Food and Drug Administration (FDA) has acknowledged that prescription drug overdoses are now the leading cause of injury-related death in America, surpassing auto accidents. [read post]
