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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 PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
PART 314 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Subpart BApplications Sec. 314.50 Content and format of an application. Applications and supplements to approved applications are required to be submitted in the form and contain the information, as appropriate
The FDA has had the responsibility of reviewing drugs since the passage of the 1906 Pure Food and Drugs Act. The 1938 Federal Food, Drug and Cosmetic Act required all new drugs to be tested before marketing by submitting the original form of the new drug application. Within the first year, the FDA's Drug Division, the predecessor to CDER ...
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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.
A lithium-titanate battery is a modified lithium-ion battery that uses lithium-titanate nanocrystals, instead of carbon, on the surface of its anode.This gives the anode a surface area of about 100 square meters per gram, compared with 3 square meters per gram for carbon, allowing electrons to enter and leave the anode quickly.
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