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13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
30 Mar 2007, 11:22 am
The Food and Drug Administration recently proposed tightening rules to minimize conflicts of interest among outside medical experts serving on agency advisory committees. [read post]
13 Jul 2010, 4:23 pm
A researcher at the Food and Drug Administration released a scathing report that had strong criticism for a major clinical trial the company has been conducting into Avandia benefits. [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
21 Sep 2007, 2:36 pm
Here's an excerpt: When the Democratic-led Congress started debating a big Food and Drug Administration bill earlier this... [read post]
2 Feb 2021, 10:00 pm
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on manufacturing considerations for certain cellular and gene therapy products during the COVID-19 pandemic. [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
28 Sep 2010, 6:19 am
USA Today: Decade after abortion pill's OK, it's not used as often as expected, by Rita Rubin: Ten years ago today, the Food and Drug Administration approved the drug mifepristone, previously known as RU-486, for the early termination of pregnancies.... [read post]
13 Jul 2004, 2:58 pm
This provision is part of a $17 billion bill to fund the Agriculture Department and the Food and Drug Administration for the next year, but is not expected to be part of the final spending bill to be reconciled [read post]
12 Jan 2009, 6:01 am
The opening: The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human... [read post]
19 Apr 2010, 5:59 am
In a paper for WLF, Brian Stimson describes the Food and Drug Administration's plans to step up its usage of a federal law under which the government can effectively end the career of high-level drug company executives who were in... [read post]
31 Mar 2016, 5:05 am
New York Times (March 31, 2016): New FDA Guidelines Ease Access on Abortion Pill, by Sabrina Tavernise: The Food and Drug Administration has updated its guidelines on mifepristone, the drug that is used for medication abortions. [read post]
30 Aug 2007, 4:55 pm
Food and Drug Administration has... [read post]
11 Apr 2007, 5:54 pm
Here's an excerpt:The Food and Drug Administration said proposed prescription painkillers should fill an unmet medical need for patients... [read post]
5 Jan 2011, 11:20 am
The Food and Drug Administration has recently banned two narcotics used for mild to moderate pain, Darvon and Darvocet, manufactured by Xanodyne Pharmaceuticals. [read post]
8 Aug 2007, 11:29 am
YOUR TAX DOLLARS AT WORK: "At least 1 million pounds of suspect Chinese seafood landed on American store shelves and dinner plates despite a Food and Drug Administration order that the shipments first be screened for banned drugs or chemicals, an Associated Press investigation found. [read post]
4 Nov 2013, 2:40 pm
Johnson & Johnson and its subsidiaries have agreed on Monday to pay over $2.2 billion to resolve criminal and civil allegations of promoting prescription drugs for uses not approved as safe and effective by the Food and Drug Administration – which was first brought to light by a Chicago-area whistle-blower. [read post]
13 Feb 2022, 10:00 pm
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors. [read post]
12 Jul 2010, 11:20 am
This week, the Food and Drug Administration (FDA) gathers its panel of outside medical experts to determine the fate of Avandia, a diabetes drug. [read post]
5 Jan 2011, 11:20 am
The Food and Drug Administration has recently banned two narcotics used for mild to moderate pain, Darvon and Darvocet, manufactured by Xanodyne Pharmaceuticals. [read post]
