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Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs (BFAD / ˈ b iː f æ d /; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Schedule X drugs - narcotics; Schedule H and L - injectables, antibiotics, antibacterials; Schedule C and C1 - biological products, for example serums and vaccines; Under manufacturing practice: Schedule N - list of the equipment for the efficient running of manufacturing wing, qualified personnel; Schedule M
The Philippines is a signatory of the United Nations Convention on Narcotic Drugs which lists psilocybin as a Schedule I substance. [36] However, the PDEA has conducted arrests of illegal drug peddlers who also sold psilocybin mushrooms alongside explicitly recognized illegal substances in the past. [37] [38]
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
List of Antiviral Drugs Antiviral Use Manufacturer Component Type Year approved Abacavir: HIV: ViiV Healthcare: Nucleoside analogue reverse transcriptase inhibitor (NRTI) 1998 Acyclovir (Aciclovir) Herpes Simplex, chickenpox, [2] varicella zoster virus: GSK: guanosine analogue RTI 1981 Adefovir: Hepatitis B [3] Gilead Sciences RTI 2002 , 2003 ...