Prescription Drug User Fee Act information

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA)...

the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration's drug approval activities in return...

most significant provisions of the act: The act reauthorized, for five more years, the Prescription Drug User Fee Act of 1992 (PDUFA). The purpose of this...

1992 – Prescription Drug User Fee Act PL 102–571 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Administration Modernization Act 105-115...

Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical...

also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical...

mission as approving as many drugs it can, regardless of whether the drugs are safe or needed" The Prescription Drug User Fee Act allows the FDA to augment...

products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood...

2019. "Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization...

product. Under current Prescription Drug User Fee Act targets, the FDA aims to complete and act upon reviews of priority drugs within six months instead...

most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center...

Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. The GDUFA was designed to build upon the 20-year-old Prescription Drug Fee Act and improve...

Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 — electronic records and electronic signature...

Services, to collect drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA process...

The United States commissioner of food and drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health...

Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application...

S. Food and Drug Administration (FDA) in June 2018, with a Prescription Drug User Fee Act (PDUFA) goal date set for 23 March 2019. It was approved for...

Amendment – requires drug manufacturers to provide proof of the effectiveness and safety of drugs before approval. Prescription Drug User Fee Act – allows the...

Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA)...

9 — Federal Food, Drug, and Cosmetic Act 21 U.S.C. ch. 10 — Poultry and Poultry Products Inspection Poultry Products Inspection Act of 1957 21 U.S.C....

cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration. He was first nominated to be commissioner in September 2015...

implementation of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), with its new Part D drug benefit, and helped advance the...

well as orphan drug and breakthrough therapy designations. Approval was granted 3.7 months ahead of the Prescription Drug User Fee Act (PDUFA) date. AbbVie...

filing and granted priority review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. On July 31, 2020, Monjuvi...

who advocated successfully for the passage of the landmark Pure Food and Drug Act of 1906 and subsequently worked at the Good Housekeeping Institute laboratories...