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20 Apr 2018, 12:09 pm
Food and Drug Administration, yet they typically involve a variation on a previously FDA-approved drug. [read post]
20 Apr 2018, 9:36 am
Food and Drug Administration announced that it would, “permit marketing of the first medical device to use artificial intelligence to detect greater than mild level of eye disease retinopathy in adults who have diabetes”. [read post]
20 Apr 2018, 7:33 am
Food and Drug Administration and the Michigan Department of Agriculture and Rural Development. [read post]
20 Apr 2018, 5:24 am
Food and Drug Administration can exclude details from Texas egg farm inspection reports on the number of hens and hen houses along with cage rows, tiers and floors per hen house.Read more here. [read post]
20 Apr 2018, 5:10 am
Food and Drug Administration, in an interview with Dr. [read post]
20 Apr 2018, 5:10 am
Food and Drug Administration, in an interview with Dr. [read post]
19 Apr 2018, 11:31 am
Peter Loftus reports for the WSJ:An advisory panel to the Food and Drug Administration recommended the agency approve what could become the first prescription drug in the U.S. [read post]
19 Apr 2018, 8:20 am
The sole purpose of the Food and Drug Administration is to regulate drug approval and make sure every drug is safe for people to use. [read post]
18 Apr 2018, 9:00 pm
Both the CDC and the Food and Drug Administration renewed their public warnings Wednesday regarding chopped romaine lettuce, specifically from the Yuma, AZ, growing area. [read post]
18 Apr 2018, 9:00 pm
The recall notice does not specify what strain of Salmonella federal inspectors found in the NxtGen kratom, but at least 132 people in 38 states have been infected in an ongoing Salmonella outbreak traced to kratom products, according to the Food ad Drug Administration’s latest list of recalled kratom products. [read post]
18 Apr 2018, 1:02 pm
As part of her employment, Sandhu entered into a confidentiality agreement and was allegedly given extensive access to Teva’s trade secrets, including confidential information about products still in development and correspondence from the Food & Drug Administration detailing how Teva might obtain approval for other products in development. [read post]
17 Apr 2018, 9:00 pm
The companies initiated the recalls following detection by the Food and Drug Administration of Salmonella in a sample from a single batch of product, according to a news release issued by Carnivore. [read post]
17 Apr 2018, 9:00 pm
Food and Drug Administration inspected the North Carolina facility and collected samples for testing. [read post]
17 Apr 2018, 1:42 pm
The mdPACE program helps medical device startups navigate the federal regulatory approval process, with a particular focus on the Food and Drug Administration’s 510(k) approval. [read post]
17 Apr 2018, 8:33 am
It’s a long process, one that was ultimately shortened in 1984 for generic drug makers, so long as they indicated their generic drug was equivalent to an approved brand name drug with the same active ingredients, administration, dosage and strength. [read post]
17 Apr 2018, 7:43 am
The Food and Drug Administration deals with food, drugs, and cosmetics. [read post]
16 Apr 2018, 6:29 pm
DPH recommends individuals wash their hands often and particularly after using the restroom or before consuming food. [read post]
16 Apr 2018, 6:15 pm
Food and Drug Administration are investigating a multistate outbreak of Salmonella Braenderup infections linked to Rose Acre Farms shell eggs. [read post]
16 Apr 2018, 8:42 am
The case involves a claim that Gilead Sciences falsely represented that the products it sold to the government complied with Food and Drug Administration regulations; Gilead Sciences contends that the court of appeals should not have allowed the case to go forward when the government paid for the products even though it knew that some of the FDA’s requirements were violated. [read post]
15 Apr 2018, 9:00 pm
Staff from the Food and Drug Administration inspected the Olympia, WA, location of Blue Heron Bakery from Nov. 28 through Dec. 6, 2017, and discovered “serious violations” of the Current Good Manfacturing Practice (cGMP) regulation for foods, according to a March 23 warning letter made public by the FDA in recent days. [read post]
