September 29, 2022 TALLAHASSEE, Fla. – This afternoon, Governor Ron DeSantis issued updates on Hurricane Ian at the State Emergency Operations Center with Division of Emergency Management Director Kevin Guthrie. Earlier today, Governor DeSantis, First Lady …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
September 30, 2022 TALLAHASSEE, Fla. – This morning, Governor Ron DeSantis issued updates on Hurricane Ian at the State Emergency Operations Center with Division of Emergency Management Director Kevin Guthrie and Federal Emergency Management Agency …
Regulating the use of radioactive drugs in basic research What is the RDRC Program? The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975 classifying all …
Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on qualification of drug development tools. Section 3011(b)(3)(A) of the 21st Century Cures Act states; “For purposes of …
September 30, 2022 TALLAHASSEE, Fla. – Esta mañana, el gobernador Ron DeSantis emitió actualizaciones sobre el huracán Ian en el Centro de Operaciones de Emergencia del Estado con el director de la División de Manejo de Emergencias, Kevin Guthrie, y la …
Welcome to the COA Compendium website! The COA Compendium is part of FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate communication and to provide clarity and transparency to drug developers and …
Helps remove barriers to generic drug development and market entry so that consumers can get access to needed medicines Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the …
Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and support for those with SUD are key priorities for the U.S. Food and Drug …
Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including …
On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma …
Summary Company Announcement Date: August 07, 2020 FDA Publish Date: August 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential fungal contamination - Aspergillus penicillioides Company Name: (Becton, Dickinson and …
September 29, 2022 | Austin, Texas | Press Release Governor Greg Abbott today announced that the State of Texas has deployed additional state resources to support Hurricane Ian response and recovery efforts in Florida. "Texans understand the urgency …
FDA is committed to enhancing the U.S. drug safety system and envisions the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA agreed to an expanded set of commitments related to scaling up and …
September 30, 2022 | Austin, Texas | Press Release Governor Greg Abbott, the Texas Department of Public Safety (DPS), and the Texas National Guard are continuing to work together to secure the border, stop the smuggling of drugs, weapons, and people into …
Assessment in Support of Sentinel System Public Report FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion and integration on FDA’s use of Sentinel for regulatory purposes. Enhancement and …
September 30, 2022 | Austin, Texas | Press Release Governor Greg Abbott today directed the Texas Division of Emergency Management (TDEM) to mobilize additional state resources to Florida to assist their response and recovery efforts following Hurricane Ian …
New benefit amounts begin Oct. 1 Media Contact: Lisa Cox Missouri Department of Health and Senior Services Media Inquiry Form JEFFERSON CITY, MO – Missouri WIC announces the extension of the temporary increase of the Cash Value Benefit for Fruit and …
Media Contact: Lisa Cox Missouri Department of Health and Senior Services Media Inquiry Form JEFFERSON CITY, MO – Paula Nickelson, acting director of the Missouri Department of Health and Senior Services (DHSS), has been appointed as Vice Chair of the …
30 September 2022 KANSAS CITY, Mo. - The Missouri Court of Appeals, Western District, will convene court Wednesday, October 19, 2022, at Missouri Western State University in St. Joseph, Missouri. The oral arguments are scheduled to begin at 9:30 a.m. in …
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