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The initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application; eliminate the batch certification and monograph requirements for insulin and antibiotics; streamline the approval processes for drug and ...
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.
These include application review fees paid by the sponsor for each drug or biologic application submitted, establishment fees paid by manufacturers annually for each of its facilities, and product fees paid annually for each product on the market covered by PDUFA. For 1993, the application review fee was about $100,000.
The typical Chinese business license includes 13 main components. These components are the Unified Social Credit Code, Company Name, Type of Company, Registered Address, Legal Representative, Registered Capital, Date of Establishment, Operation Period, Business Scope, Issuing Authority, Date of Issuance, Official Stamp or Seal, and License Format.
A certificate of incorporation is a legal document/license relating to the formation of a company or corporation. It is a license to form a corporation issued by the state government or, in some jurisdictions, by a non-governmental entity/corporation. [1] Its precise meaning depends upon the legal system in which it is used.
Sex establishment licence; List of state soil science licensing boards; ... Text is available under the Creative Commons Attribution-ShareAlike 4.0 License; ...
Gaming control boards also have complete authority to grant or deny licenses to gaming establishments, their ownership, employees, and vendors. Generally, in order to obtain a license, an applicant must demonstrate that they possess good character, honesty and integrity. License application forms typically require detailed personal information.
register or a list of a specified type of regulated entities or activities — contains entries on companies officially authorized to perform a specified type of business, where prior obtaining of a permit, a license, a concession, or registration on such a list or register is a prerequisite required by law. Depending on situation, regulation ...