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25 Apr 2024, 9:46 am
by Dennis Crouch This post walks through a new petition for writ of certiorari involving claims that Valeant Pharma defrauded the U.S. government by using fraudulently obtained patent rights prop up its drug prices. [read post]
25 Apr 2024, 6:41 am
To illustrate this point, we’re summarizing highlights of the hundreds of FOIA requests submitted by media organizations to the Food and Drug Administration and the Securities and Exchange Commission during March (the most recent month for which information is available). [read post]
24 Apr 2024, 5:59 am
Last fall, the drug manufacturer Eli Lilly received approval from the Food and Drug Administration (FDA) for a new medication for chronic weight management. [read post]
23 Apr 2024, 9:01 pm
The United States requested clarification on whether a certificate issued by the Food and Drug Administration (FDA) to foreign governments for products covered by the notice would be acceptable. [read post]
22 Apr 2024, 9:02 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
22 Apr 2024, 7:06 pm
Houck —Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August. [read post]
22 Apr 2024, 2:49 pm
” By contrast, Justice Clarence Thomas emphasized that the law at issue in Robinson barred both the use of drugs and being addicted to drugs. [read post]
22 Apr 2024, 10:44 am
Food and Drug Administration for such use, not advocated for by the National Comprehensive Cancer Network, and not within St. [read post]
22 Apr 2024, 7:30 am
The claimed differences over the prior art, like administering without food or avoiding co-administration with certain drugs, seem relatively weak from an innovation perspective. [read post]
22 Apr 2024, 4:56 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 21, 2024, and is ongoing. [read post]
21 Apr 2024, 9:05 pm
Food and Drug Administration has announced a priority review of the first psychedelic new drug indication—MDMA-assisted therapy for PTSD. [read post]
21 Apr 2024, 9:03 pm
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. [read post]
19 Apr 2024, 11:20 am
According to the details posted online by the Food and Drugs Administration (FDA), the recall was initiated on March 21, 2024, and is ongoing. [read post]
18 Apr 2024, 9:01 pm
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
18 Apr 2024, 12:52 pm
Consider the Food and Drug Administration’s Regulations 21 C.F.R. 801.415 is a regulation of the Food and Drug Administration (“FDA”), which provides: “Ozone is a toxic gas with no known useful medical application in specific adjunctive, or preventative therapy. [read post]
17 Apr 2024, 9:05 pm
Food and Drug Administration (FDA) for new drugs. [read post]
16 Apr 2024, 9:05 pm
Food and Drug Administration—about if and how we want to decriminalize psychedelics.The post Are Psychedelics Safe Enough for Recreational Use? [read post]
16 Apr 2024, 9:04 pm
The new approach by the Food and Drug Administration is designed to provide post-incident response action. [read post]
16 Apr 2024, 3:44 pm
Food and Drug Administration of the outbreak on April 9. [read post]
16 Apr 2024, 8:42 am
Regeneron Pharmaceuticals and Ocular Therapeutix teamed up to file their own amici curiae brief in support of Salix, in which they attributed the increasing use of clinical trial protocol summary disclosures as evidence of a “reasonable expectation of success” in the obviousness analysis to the enactment in 2007 of the Food and Drug Administration Amendments Act, which greatly expanded the number of trials requiring disclosure, which was… [read post]
