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13 Mar 2024, 7:24 pm
§ 1.750, applicant is required to submit the following to the USPTO: Evidence that Biogen MA Inc. is expressly authorized to rely upon the regulatory review activities by Biogen, Inc., the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. [read post]
12 Mar 2024, 7:33 pm
The NYT story:When anti-abortion activists sued the Food and Drug Administration in 2022 seeking to overturn the approval of the abortion drug mifepristone, they filed their suit in the federal court in Amarillo, Texas, where it was all but assured that the case would be heard by Judge Matthew J. [read post]
12 Mar 2024, 12:27 pm
If the administrative state is weakened, it will be easier to challenge various regulations that help to ensure that the air and water are kept clean and that consumer products such as food, drugs, and cars are safe. [read post]
12 Mar 2024, 11:18 am
On February 28, 2024, the Food and Drug Administration (FDA) announced that all grease-proofing agents containing per- and polyfluoroalkyl substances (PFAS)[1] “are no longer being sold for use in food packaging in the U.S. [read post]
12 Mar 2024, 5:00 am
Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly. [read post]
12 Mar 2024, 4:42 am
The team delivered food, 24,050 liters of fuel, and medical supplies for 42,000 patients, which included anesthetic drugs, surgical materials and medicine, Ghebreyesus said. [read post]
10 Mar 2024, 1:53 pm
Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. [read post]
9 Mar 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]
8 Mar 2024, 8:14 pm
The first gene editing therapy utilizing CRISPR/Cas-9, called Casgevy, was approved by the Food and Drug Administration (FDA) in December of 2023. [read post]
8 Mar 2024, 6:02 pm
January 6th lies about the 2020 election and the plots to steal the election posed a great — gravest threat to U.S. democracy since the Civil War. [read post]
8 Mar 2024, 2:56 pm
The Food and Drug Administration has issued a warning about certain mussels from Allen’s Fisheries in Newfoundland, Canada, that were imported to the United States. [read post]
7 Mar 2024, 9:05 pm
Food and Drug Administration (FDA) approved eye drops developed by Eyenovia to reduce inflammation and pain in patients post-cataract eye surgery. [read post]
7 Mar 2024, 7:42 pm
Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this year. [read post]
7 Mar 2024, 12:50 pm
Food and Drug Administration (FDA) has not approved. [read post]
7 Mar 2024, 9:49 am
Federal Food and Drug Administration, (FDA) initiated an investigation into the dental problems associated with the use of Suboxone, after receiving many complaints on its website. [read post]
7 Mar 2024, 7:58 am
The U.S. [read post]
7 Mar 2024, 5:29 am
Food and Drug Administration. [read post]
7 Mar 2024, 5:28 am
Food and Drug Administration v. [read post]
6 Mar 2024, 9:01 pm
A Flawed Process Even without the major questions doctrine and concerns about statutory authority, the Commission conducted a flawed process by not re-proposing the rule, raising the question of whether appropriate notice was provided under the Administrative Procedure Act.[7] The Commission proposed this rulemaking nearly two years ago and received thousands of comment letters. [read post]
6 Mar 2024, 4:30 pm
The Food and Drug Administration is also logging patients in the outbreak. [read post]
