Biologic definition

Biologic means a drug that is produced or distributed in accordance with a biologics license

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Biologic means a drug that is produced or distributed in accordance with

Biologic or a "Drug", as the case may be), each such Medical Device, Biologic or Drug is being developed, manufactured, tested, distributed and/or marketed in compliance with all applicable requirements under the FDCA and similar Legal Provisions, including those relating to investigational use, premarket clearance or marketing approval to market a Medical Device, and applications or abbreviated applications to market a new Biologic or a new Drug, good manufacturing practices, labeling, advertising, record keeping, filing of reports and security, except for failures in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received any material notice or other material communication from the FDA or any other Governmental Entity (A) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Company or any of its Subsidiaries or (B) otherwise alleging any violation applicable to any Medical Device, Biologic or Drug by the Company or any of its Subsidiaries of any Legal Provision.

Examples of Biologic in a sentence

For the avoidance of doubt, no contingent payment right is granted to Company hereunder with regard to any Biovest activity other than the Biovest Biologic Products, and no right, interest, or license to use any Biovest Biologic Product (or other product or intellectual property of Biovest or its Affiliates) is granted under this Agreement whatsoever.
Biologic medications may be substituted by biosimilar products or by FDA-approved brand mediations marketed without the brand on their label (authorized brand alternatives at any time during the contracted coverage year.
The address for such notices and communications shall be as follows: If to the Company: China Biologic Products, Inc.
Biologic, psychological, and social components of illnesses are explored and understood in treatment of the whole person.
This Agreement and the obligations set forth herein shall be binding on the survivor of any merger or consolidation of Biovest or further shall be binding on any purchaser from Biovest of the assets constituting any Biovest Biologic Product.

More Definitions of Biologic

Biologic means a biological product, as defined in 42 U.S.C. §262(i)(1).

Biologic means any product (such as a globulin, serum, vaccine, antitoxin, antigen or analogous product) used in the prevention of treatment of sickness or disease. Biologic products also include blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors.

Biologic means a "biological product", as defined in 42 USC 262(i), as amended from time to time, that is regulated as a drug under the federal Food, Drug and Cosmetic Act, 21 USC 301 et seq. ;

Biologic means any [***] or a [***].

Biologic means a drug that is produced or distributed in

Biologic means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.

Biologic means any composition of matter comprising proteins, nucleic acids, carbohydrates, or any combination of these substances, including antibodies (derivatives or fragments thereof), other binding proteins, peptide molecules, RNA molecules, DNA molecules, viruses, gene therapy vectors, genetically engineered cells, and chemically modified cells.