The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The U.S. Food and Drug Administration (FDA) published the fiscal year 2014 generic drug user fees as required under the Generic Drug User Fee Amendments of 2012 (GDUFA) in the Federal Register. FDA is aware that industry is adjusting to the new requirements and fees, and FDA minimized the increase in fees as much as possible. As specified in the statute, the fiscal year 2014 fees include an increase over the 2013 fees. In the first year of the program (2013), the total revenue included a one-time fee for applications pending as of October 1, 2012. With this one-time fee removed from the calculation, the remaining fees make up the total revenue, which resulted in the increase. Additional factors, including the number of facilities that self-identify under GDUFA, are also used in calculating the facility fee. FDA Announces Fiscal Year 2014 Generic Drug Fees The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), which was signed by the President on July 9, 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, for certain applications and supplements for approval of biosimilar biological... The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue... FDA’s Drug Shortages website has a new feature: Therapeutic Categories. In addition to the A-Z index, Therapeutic Categories are now available. The A-Z index lists drugs in alphabetical order by generic name or active ingredient. The new Therapeutic Categories tab shows drugs in shortage by categories. Therapeutic Category is based on indications and commonly used population, as in Pediatrics, Oncology, Anesthesia, and more. The category designation does not indicate FDA approval status. For FDA approved drug products, continue to refer to Drugs@FDA. If you have questions or feedback, please notify Drug Shortages at drugshortages@fda.hhs.gov. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a previously issued draft guidance on the same subject. Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). Biosimilar User Fee Rates for Fiscal Year 2014
Prescription Drug User Fee Rates for Fiscal Year 2014
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
| This email was sent to buzzhairs.health@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
No comments:
Post a Comment