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The FAA prioritizes its review of a new application based on its internal process called Project Prioritization. [5] The FAA Order covering the application for PMA is Order 8110.42 revision D. This document is worded as instructions to the FAA reviewing personnel. An accompanying Advisory Circular (AC) 21.303-4 is intended to address the ...
Priority review vouchers are currently earned by pharmaceutical companies for the development and approval of drugs treating neglected tropical diseases, rare pediatric diseases, and "medical countermeasures" for terrorism. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Appearance Approval Report A copy of the AAI (Appearance Approval Inspection) form signed by the customer. Applicable for components affecting appearance only. Sample Production Parts A sample from the same lot of initial production run. The PPAP package usually shows a picture of the sample and where it is kept (customer or supplier). Master ...
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. Once approved, an ...
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need.
A System Design Review (SDR) is a scheduled review of many government-contractor relations, which ensures continuous involvement throughout a program. The SDR was originally defined in the Air Force's MIL-STD-1521.
Sustained-release dosage forms are dosage forms designed to release (liberate) a drug at a predetermined rate in order to maintain a constant drug concentration for a specific period of time with minimum side effects. This can be achieved through a variety of formulations, including liposomes and drug-polymer conjugates (an example being ...