Search results
Results From The WOW.Com Content Network
Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. [3] [4] It is a small molecule inhibitor of HER2. [6] [7] It was developed by Array BioPharma and licensed to Cascadian Therapeutics (formerly Oncothyreon, subsequently part of Seattle Genetics ). [8]
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 ...
A biologics license application ( BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
The Vaporized Nicotine and Non-Nicotine Products Regulation Act, officially recorded as Republic Act No. 11900, is a law in the Philippines which aims to regulate the "importation, sale, packaging, distribution, use and communication of vaporized nicotine and non-nicotine products and novel tobacco products", such as electronic cigarettes and heated tobacco products. [1]
The national drug code is a unique 10 or 11 digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment, the labeler code, is ...
Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
The Philippines ' National Food Authority ( Filipino: Pambansang Pangasiwaan ng Pagkain, abbreviated as NFA ), is an agency of the Philippine government under the Department of Agriculture responsible for ensuring the food security of the Philippines and the stability of supply and price of rice, the Philippines' staple grain .