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Quizlet was founded in October 2005 by Andrew Sutherland, who at the time was a 15-year old student, [2] and released to the public in January 2007. [3] Quizlet's primary products include digital flash cards , matching games , practice electronic assessments , and live quizzes.
The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research ...
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
Prior to the roll-out of Python 3, projects requiring compatibility with both the 2.x and 3.x series were recommended to have one source (for the 2.x series), and produce releases for the Python 3.x platform using 2to3. Edits to the Python 3.x code were discouraged for so long as the code needed to run on Python 2.x. [10]
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
The Python Software Foundation License (PSFL) is a BSD-style, permissive software license which is compatible with the GNU General Public License (GPL). [1] Its primary use is for distribution of the Python project software and its documentation. [3] Since the license is permissive, it allows proprietization of the derivations.
If the Form 356h is missing information, the FDA will reply within 74 days. [3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval.