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21 Nov 2017, 9:03 pm
Department of Agriculture and the Food and Drug Administration on the investigation. [read post]
21 Nov 2017, 8:02 pm
” The Multidisciplinary Association for Psychedelic Studies (MAPS) “is undertaking a roughly $25 million plan to make MDMA into a Food and Drug Administration (FDA)-approved prescription medicine by 2021. [read post]
21 Nov 2017, 8:00 pm
According to the 2016 Food and Drug Administration Food Safety Survey, 68 percent of consumers wash poultry in the kitchen sink, which is not recommended by the USDA. [read post]
21 Nov 2017, 2:40 pm
Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), this leading drug safety publication ends its recent report on Entresto with these statements in the final Conclusions section: This large volume of reports of hypotension confirms the concerns of FDA reviewers that the [Entresto (valsartan-sacubitril)clinical trial results in carefully selected patients underestimated the risk of hypotension in normal clinical practice. [read post]
21 Nov 2017, 8:06 am
Second, the Corporation argued that the district court abused its discretion by excluding all evidence relating to the Food and Drug administration’s clearance of the mesh for sale through the FDA’s “substantial equivalence” process. [read post]
21 Nov 2017, 8:06 am
Second, the Corporation argued that the district court abused its discretion by excluding all evidence relating to the Food and Drug administration’s clearance of the mesh for sale through the FDA’s “substantial equivalence” process. [read post]
20 Nov 2017, 5:07 pm
Food and Drug Administration after random sample testing found Listeria monocytogenes in two sampled packages. [read post]
20 Nov 2017, 2:56 pm
Food and Drug Administration (FDA) continues to receive reports of issues with the NuVasive Magec System that include:Rods failing to properly extend or expandRods not engaging properlyRods bending, breaking or separatingFractures of the pins used to stabilize the rodNuVasive Specialized Orthopedics, Inc., has the full responsibility to its pediatric patients and their families. [read post]
20 Nov 2017, 10:57 am
For an update on the Food & Drug Administration’s guidance on the compounding of animal drugs from bulk drug substances and the labeling of pet medications, see Nancy Halpern’s recent blog post on Fox Rothschild’s Animal Law blog. [read post]
19 Nov 2017, 9:00 pm
Staff from the Food and Drug Administration inspected the Ixonia, WI, location of Create-A-Pack Foods Inc. from Jan. [read post]
18 Nov 2017, 2:28 pm
Food and Drug Administration random sample testing program. [read post]
18 Nov 2017, 10:03 am
January 19 is the deadline to comment on a petition asking the Food and Drug Administration (FDA) to exempt over-the-counter (OTC) denture repair kits from the premarket notification requirements. [read post]
17 Nov 2017, 9:00 pm
The business appears to have continued operating, according to a notice from the U.S Food and Drug Administration on Friday evening. [read post]
16 Nov 2017, 9:30 pm
Food and Drug Administration (FDA) approved Abilify MyCite, a pill with an ingestible sensor that tracks whether patients have taken their medication. [read post]
16 Nov 2017, 9:00 pm
On November 15, the US Food and Drug Administration (FDA) published a draft guidance on best practices to help parties interested in convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use. [read post]
15 Nov 2017, 9:01 pm
Food and Drug Administration after routine environmental sampling found Listeria monocytogenes in the processing environment and in one sample of “Original Tahini Sauce. [read post]
15 Nov 2017, 9:00 pm
Casa Sanchez Foods of Hayward, CA, is recalling its 9-ounce containers of “Real Guacamole” because testing by the Food and Drug Administration confirmed Listeria monocytogenes in a sample of the product. [read post]
14 Nov 2017, 9:02 pm
State and local health agencies and the U.S.Food and Drug Administration have not said anything about Gate Gourmet’s status at LAX or just how long ago the first positive tests for Listeria occurred. [read post]
13 Nov 2017, 9:00 pm
The problem was discovered by Food and Drug Administration inspectors during environmental sampling at the Manchester, NH, facility, which identified Listeria in the processing environment. [read post]
13 Nov 2017, 1:46 pm
Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition. [read post]
