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On 11 March 2005, the FDA issued a letter to Sidney M. Wolfe of Public Citizen both denying the petition and providing an extensive detailed analysis of findings that demonstrated no basis for concerns about rosuvastatin compared with the other statins approved for marketing in the United States. [53]
FROM: Thomas P. Laughren, M.D. Director, Division of Psychiatry Products HFD-130 SUBJECT: Recommendation for approvable action for Risperdal (risperidone) for the treatment of irritability associated with autistic disorder TO: File NDAs 20-272/S-036, 20-588/S-024 and 21-444/S-008
Regenerative Medicine Advanced Therapy (RMAT) is a designation given by the Food and Drug Administration to drug candidates intended to treat serious or life-threatening conditions under the 21st Century Cures Act. [1] A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. [2]
The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. The complete list of Schedule V substances is as follows.
An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
If the file has been modified from its original state, some details may not fully reflect the modified file. Short title Commission Regulation (EC) No 105/2005 of 17 November 2004 amending Council Regulation (EC) No 1420/1999 and Regulation (EC) No 1547/1999 as regards shipments of certain types of waste to China and Saudi Arabia (Text with EEA ...
The following is a list of WHO recommended strains for the Northern Hemisphere influenza season. Starting in the 2012–2013 season, the recommendation shifted to include the composition of a quadrivalent influenza vaccine (QIV) that contains both influenza B lineages, alongside a trivalent influenza vaccine (TIV) containing one influenza B lineage.
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act, also known as the "Wiley Act" after its chief advocate. [1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority ...