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13 Nov 2019, 1:04 pm
The company’s antibiotic Zemdri, was reportedly approved by the Food and Drug Administration in June 2018, yet Achaogen reportedly entered bankruptcy less than a year later, “despite multiple reductions to its workforce and R&D ambitions,” according to an article in BioPharma Dive. [read post]
13 Nov 2019, 9:27 am
As she reported of the Federal Food and Drug Administration: Continue reading [read post]
13 Nov 2019, 9:15 am
Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018), the Petitioners relied on a copyrighted label for Rituxan that was published on the internet and available on the Food and Drug Administration’s (FDA’s) and on Biogen’s website all before the critical date. [read post]
13 Nov 2019, 9:02 am
USDA rules specifically note that uses of CBD remain under the jurisdiction of the Food and Drug Administration. [read post]
12 Nov 2019, 9:02 pm
Food and Drug Administration (FDA) to investigate the source of the tuna to make sure appropriate storage and handling of tuna is happening before distribution to restaurants and other food establishments,” according to the health department’s notice. [read post]
12 Nov 2019, 2:13 pm
H.R.3055 Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020 6. [read post]
12 Nov 2019, 2:12 pm
Lipocine Complete Response Letter (CPL) On Monday November 11, 2019, Lipocine said it received a CRL (Complete Response Letter) from the Food and Drug Administration regarding its new drug application for TLANDO, a candidate for testosterone replacement treatment. [read post]
12 Nov 2019, 1:21 pm
The recall notice from Russ Davis Wholesale, posted by the Food and Drug Administration, says the company delivered the implicated products to retail stores in Minnesota, Wisconsin, North Dakota, South Dakota, Illinois, Indiana, Michigan, Iowa, Montana, Nebraska and Wyoming. [read post]
12 Nov 2019, 12:39 pm
The company’s recall notice, posted by the Food and Drug Administration, says no illnesses or injuries have been reported to date in connection with either Mann’s or Taher’s recall. [read post]
11 Nov 2019, 11:26 pm
Food and Drug Administration (FDA) each year, suspecting pharmacy medication errors. [read post]
11 Nov 2019, 12:03 pm
Food and Drug Administration says that Juul products, which are produced by Juul Labs, based in San Francisco, represent a sizable share of the e-cigarette market. [read post]
11 Nov 2019, 11:12 am
Food and Drug Administration (FDA). [read post]
11 Nov 2019, 9:00 am
Food and Drug Administration (“FDA”) has announced its intent to withdraw its Compliance Policy Guide 400.400 (1988) (“CPG 400.400”) for homeopathic drug products pursuant to which such products have been permitted to be marketed without having to comply with the new drug, adulteration and misbranding requirements that are otherwise applied to all drug products. [read post]
11 Nov 2019, 6:44 am
JUUL Made False Marketing Claims (To Young Adults) In September 2019, the Food & Drug Administration (FDA) issued a warning letter to JUUL Labs. [read post]
10 Nov 2019, 9:04 pm
As part of its enforcements, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
9 Nov 2019, 9:03 pm
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
8 Nov 2019, 6:53 pm
The alert from the USDA’s Food Safety and Inspection Service (FSIS) tonight says the products contain recalled ingredients that fall under the jurisdiction of the Food and Drug Administration. [read post]
8 Nov 2019, 4:06 pm
Editor’s note: At this time, the credibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) is not to be trusted. [read post]
8 Nov 2019, 3:46 pm
The voluntary recall is a response to a notification by the Food and Drug Administration and the Canadian Food Inspection Agency of a potential contamination with Listeria monocytogenes. [read post]
8 Nov 2019, 9:41 am
Among its many important functions, the liver manufactures enzymes that aid in food digestion, stores sugar and nutrients, and helps the body fight infection. [read post]
