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13 Dec 2020, 9:01 pm
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. [read post]
11 Dec 2020, 6:56 pm
Notable Events of the Week: “The Food and Drug Administration accelerated its timeline for issuing an emergency authorization for Pfizer’s Covid-19 vaccine after President Trump’s chief of staff, Mark Meadows, told Dr. [read post]
11 Dec 2020, 12:58 pm
Additionally, the vaccines now being considered for distribution will likely be distributed pursuant to the Emergency Use Authorization (“EUA”) authority of the Food and Drug Administration (“FDA”), which mandates less rigorous review of vaccines than that required for full FDA licensure. [read post]
11 Dec 2020, 12:15 pm
The Food and Drug Administration is aiming to issue an emergency authorization for Pfizer’s COVID-19 vaccine by Friday evening, reports the New York Times. [read post]
11 Dec 2020, 5:11 am
Despite a determination by the Department of Health and Human Services (“HHS”) that laboratory developed tests (“LDTs”) do not require premarket approval, the Food and Drug Administration (“FDA”) has asserted that the at-home collection kit portion of a COVID-19 LDT does require FDA pre-market approval. [read post]
11 Dec 2020, 4:44 am
It requires a food and general retail establishment to notify hourly e [read post]
11 Dec 2020, 4:05 am
Food and Drug Administration, (D MD, Dec. 9, 2020), a Maryland federal district court refused to stay its earlier preliminary injunction against enforcement during the COVID emergency of an FDA rule that prevents mifepristone, an oral medication used to induce abortion, from being received by mail or through a pharmacy. [read post]
10 Dec 2020, 9:05 pm
Food and Drug Administration (FDA) food code to state efforts to implement the federal Food Safety Modernization Act. [read post]
10 Dec 2020, 3:05 pm
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as ... [read post]
10 Dec 2020, 1:45 pm
Food and Drug Administration (FDA) to treat IC. [read post]
10 Dec 2020, 1:35 pm
An advisory panel for the Food and Drug Administration (FDA) met today to decide whether to approve the new Pfizer-BioNTech coronavirus vaccine. [read post]
10 Dec 2020, 8:50 am
Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee “reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases…. [read post]
9 Dec 2020, 1:15 pm
Food and Drug Administration. [read post]
9 Dec 2020, 12:11 pm
Herz, an administrative law professor at the Cardozo School of Law. [read post]
8 Dec 2020, 9:05 pm
Food and Drug Administration (FDA) places federal requirements on food product labels, but FDA does not pre-approve labels before they enter the market. [read post]
8 Dec 2020, 9:03 pm
Food and Drug Administration establish the identity of a person selling DNP on the dark web. [read post]
8 Dec 2020, 5:08 pm
As of November 30, 2020, several companies, including Pfizer and Moderna, had requested emergency use authorization from the Food and Drug Administration (FDA) for their vaccine candidates. [read post]
8 Dec 2020, 1:01 pm
The Food and Drug Administration (FDA) affirmed today that Pfizer’s two-dose vaccine is 95 percent effective, as the company had previously reported. [read post]
8 Dec 2020, 1:00 pm
In response to an Abbreviated New Drug Application (ANDA) filed with the Food and Drug Administration (FDA) by Ajanta Pharma Ltd., Merck is suing for alleged patent infringement.[1] The patent in question is U.S. [read post]
8 Dec 2020, 12:28 pm
Food and Drug Administration, rather than a full licensure. [read post]
