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16 Aug 2019, 8:31 am
Food and Drug Administration. [read post]
16 Aug 2019, 6:49 am
Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. [read post]
16 Aug 2019, 6:25 am
In May, the Food and Drug Administration approved Poseida's CIRM-backed product as an orphan drug treatment for multiple myleoma, a disease that affects 300,000 Americans every year. [read post]
15 Aug 2019, 11:04 pm
Food and Drug Administration. [read post]
15 Aug 2019, 7:23 am
Kellogg conceded that “the FDA has not promulgated a formal regulation authorizing food manufacturers to associate consumption of whole grains with cardiovascular disease” but argued that Statement 2 should be considered authorized because it was similar to two claims that the FDA approved via the streamlined process outlined in the Food & Drug Administration Modernization Act of 1997 (FDAMA). [read post]
15 Aug 2019, 3:58 am
., including, the Food and Drug Administration, the Consumer Product Safety Commission (CPSC), and the Environmental Protection Agency, in addition to others. [read post]
14 Aug 2019, 1:00 pm
Food and Drug Administration must include, both visually and verbally, the following statement: “Do not stop taking a prescribed medication without first consulting a physician. [read post]
14 Aug 2019, 1:00 pm
Food and Drug Administration must include, both visually and verbally, the following statement: “Do not stop taking a prescribed medication without first consulting a physician. [read post]
14 Aug 2019, 11:23 am
The concerning incidents involve “pay to play” clinical trials and “manipulated” data submitted to the federal Food and Drug Administration by maker Novartis as part of the approval process for a gene therapy drug with a sky-high price. [read post]
14 Aug 2019, 8:26 am
Other OPPS policy proposals include the following, among many others: CMS proposes an alternative pathway for OPPS device pass-through payment status for transformative devices with Food and Drug Administration Breakthrough Device designation. [read post]
14 Aug 2019, 8:17 am
Click on the image to enlarge it.But, the Food and Drug Administration “sampling assignment” that was associated with the 2018 outbreak that killed five people and sickened at least 210 across 27 states did not focus on processing facilities. [read post]
13 Aug 2019, 11:05 pm
A Salmonella outbreak earlier this year that was linked to imported tahini is behind the enforcement move by the Food and Drug Administration. [read post]
13 Aug 2019, 9:01 pm
The statute in question, the Food, Drug, and Cosmetic Act, did not make clear that judicial review was limited to its special review provisions. [read post]
13 Aug 2019, 3:08 pm
Centers for Disease Control and Prevention, the Food and Drug Administration, and the U.S. [read post]
13 Aug 2019, 1:28 pm
As the GAO noted, there was no scientific basis for these claims.[4] As a result of the GAO’s findings, in 2006 the Centers for Disease Control (CDC), in conjunction with the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued consumer alerts warning the public to be wary of the claims being made by many of these genetic testing companies. [read post]
13 Aug 2019, 8:04 am
Numerous Democratic senators authored a letter to the Food and Drug Administration (FDA) on Friday to urge the agency to take action against a drug company that hid falsified data while seeking approval for the most expensive gene therapy in US history. [read post]
11 Aug 2019, 11:01 pm
The Food and Drug Administration recently sent warning letters to a Florida bakery, a New York ready-to-eat (RTE) food manufacturer, and seafood processors in Maine and Korea because inspectors found significant violations of U.S. food safety laws at their operations. [read post]
10 Aug 2019, 12:39 pm
According to the recall notice posted on The Food and Drug Administration’s website, the recall was issued due to a sample of baby spinach that yielded a positive result for Salmonella in a random test conducted by the Department of Agriculture in Michigan. [read post]
9 Aug 2019, 8:58 am
CHICAGO (August 9, 2019) – The US Food and Drug Administration has received at least 127 reports of seizures or other neurological symptoms possibly related to e-cigarettes, the agency announced this week. [read post]
8 Aug 2019, 11:03 pm
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
