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4 Jan 2024, 10:00 pm
The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration (FDA), recently issued a policy statement describing how the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits “unfair methods of competition. [read post]
10 Nov 2010, 9:39 pm
By James DeGiulio -- Last week, the Food and Drug Administration began gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"). [read post]
20 Aug 2020, 10:59 am
Rockville-based American Gene Technologies (AGT) Thursday was approved by the Food and Drug Administration (FDA) to begin Phase 1, the first human clinical trial for AGT’s lead HIV program. [read post]
18 Jan 2014, 12:15 pm
While the Food and Drug Administration refuses to recognize the benefits of medicinal marijuana, leading experts classify cannabis as a botanical medicine. [read post]
20 Apr 2018, 9:36 am
Food and Drug Administration announced that it would, “permit marketing of the first medical device to use artificial intelligence to detect greater than mild level of eye disease retinopathy in adults who have diabetes”. [read post]
4 Sep 2017, 7:30 am
Mass Device reports that the Food and Drug Administration “released information on a select recall of Medtronic’s Newport HT70 and HT70 Plus ventilators over software issues which could cause unexpected shutdowns. [read post]
18 Feb 2011, 4:02 pm
The Food and Drug Administration has been very concerned about the injury risks from the use of metal-on-metal hip replacement devices. [read post]
10 Nov 2020, 4:15 am
Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in a Hatch-Waxman case “only when and where an ANDA-filer submits its ANDA to the FDA [Food and Drug Administration] or occurs wherever future distribution of the generic is contemplated. [read post]
16 Dec 2020, 10:00 pm
On the heels of the US Food and Drug Administration’s first issuance of an Emergency Use Authorization for a coronavirus (COVID-19) vaccine, the Equal Employment Opportunity Commission published an updated technical assistance bulletin that begins to address some of the questions employers have raised regarding whether they can require employees to get vaccinated for COVID-19, as well as considerations employers should be aware of if they do offer a COVID-19… [read post]
16 Nov 2018, 5:01 pm
On Thursday, the Food and Drug Administration announced a series of regulations meant to combat youth abuse of flavored e-cigarettes and tobacco products. [read post]
5 May 2016, 3:00 pm
That’s what consumer group Public Citizen said to the Food and Drug Administration last Wednesday when it it sued the federal agency for professional background information on its advisors. [read post]
23 Mar 2017, 9:17 am
Food and Drug Administration issued an update this week regarding certain types of breast implants connected to anaplastic large cell lymphoma. [read post]
9 Nov 2023, 9:15 am
Food and Drug Administration’s (FDA) Orange Book. [read post]
2 May 2021, 10:00 pm
Despite having authority to issues such notices since the 2007 passage of the Food and Drug Administration Amendments Act (FDAAA), FDA has not previously exercised its clinicaltrials.gov enforcement authority. [read post]
16 Oct 2006, 10:15 am
Lester Crawford [official website], a veterinarian who served briefly as commissioner of the US Food and Drug Administration (FDA) [official website] last year, will plead guilty to failure to disclose his financial interest in companies regulated by the agency, his lawyer said Monday. [read post]
4 Jun 2008, 11:20 am
., citing Matrix's application earlier this year with the Food and Drug Administration to sell a generic version of Azor. [read post]
17 Jan 2022, 10:00 pm
In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement policy guidance to permanent marketing authorization. [read post]
15 Mar 2012, 5:32 am
The Food and Drug Administration (FDA) plans to hold a public hearing on May 11, 2012, from 8:30 a.m. to 5 p.m., to gather feedback on its recently released draft biosimilars guidance documents. [read post]
4 Jan 2013, 7:37 am
Four months after inspecting the farm, Food and Drug Administration officials suggested that the owner of Chamberlain Farm Produce Inc. check his operation for “a source of wide-spread contamination” in relation to a salmonella outbreak that sickened 261 and killed three in 2012.http://www.thepacker.com/fruit-vegetable-news/FDA-suggests-widespread-contamination-at-Chamberlain-Farms-185555432.html [read post]
2 Apr 2009, 9:47 am
[JURIST] The US House of Representatives [official website] passed a bill [H.R. 1256 text, PDF] Thursday that would give the US Food and Drug Administration (FDA) [agency website] the authority to regulate the market for tobacco products. [read post]
