FDA Regulations definition

FDA Regulations means any Laws relating to or administered by the FDA.

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FDA Regulations shall have the meaning ascribed to it in Section 3.1(t)(iii).

FDA Regulations has the meaning set forth in Section 4.31(b).

Examples of FDA Regulations in a sentence

• University does not perform any services under this agreement that may be subject to FDA Regulations, e.g. GMP, cGMP, GLP, GCP work/services.

• Each Credit Party will comply, and shall cause each of its Subsidiaries and all other Persons, if any, on or occupying any Facilities to comply, with the requirements of all applicable laws, rules, regulations and orders of any Governmental Authority (including all Environmental Laws, FDA Regulations and HHS Regulations), noncompliance with which could reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

• FDA Regulations: Each exhibitor must comply with all FDA regulations.

• Each Credit Party will, and will cause each of its Subsidiaries to, comply with all laws, rules, regulations and orders, and all applicable restrictions imposed by all Governmental Authorities, applicable to it and its Property (including, without limitation, the FDA Regulations and the HHS Regulations) if noncompliance with any such law, rule, regulation, order or restriction would reasonably be expected to have a Material Adverse Effect.

• The Borrowers shall, and shall cause their Subsidiaries to, (i) comply in all material respects with federal, state and other applicable securities laws, and (ii) comply in all material respects with the requirements of all other applicable laws, rules, regulations and orders of any Governmental Authority (including all Environmental Laws, FDA Regulations and HHS Regulations).

• To the extent that any product of the Business does not meet the statutory definition of "device," said product(s) is being developed, manufactured, tested, distributed and marketed in full compliance with all applicable requirements under the FD&C Act, FDA Regulations, and FDA policies and guidelines.

• Each member of the Seller Group has conducted, and is conducting, the Business in compliance with all applicable Laws, FDA Regulations, FDA Authorizations and requirements for certification pursuant to ISO 13485:2003 (“ISO Requirements”).

• The principles to be observed by AMAR and CYTOB in such public disclosures will be: accuracy, compliance with FDA Regulations and other FDA guidance documents and other Applicable Laws, the advantage a competitor of AMAR or CYTOB may gain from any public statements under this Section 15.02, and the standards and customs in the biotechnology and pharmaceutical industries for such disclosures by companies comparable to AMAR and CYTOB.

• The activities performed by Novel under ------------------------ this agreement will be performed in substantial compliance with all applicable FDA Regulations, EN46001/ISO 9001, and certain portions of the Medical Device Directive (EC Council Directive 93/42/EEC) (the "MDD") as defined in Article 2, Section 8 below, and other US federal, state and local laws, rules, regulations, quality standards and guidelines.

• All manufacturing facilities Related to the Business are operated, and Books and Records maintained, in compliance with applicable FDA Regulations and ISO Requirements.

More Definitions of FDA Regulations

FDA Regulations means the Food and Drugs Regulations, C.R.C., c. 870, made under the FDA;

FDA Regulations means all rules, regulations, directives, decrees, protocols, codes, guidelines, interpretations, policies, Authorizations or Laws (including the US Food Drug and Cosmetic Act and the Food and Drugs Act of Canada) issued or administered by any FDA Authority, including those relating to investigational use, investigational device exemption, premarket notification, premarket approval, approval, 501(k) clearance, good clinical and good laboratory practices, good manufacturing practices, record keeping, filing of reports, packaging, labeling, testing, advertising, problem and complaint investigations and handling, and patient medical record security.

FDA Regulations means the rules and regulations of the FDA, regardless of having the effect of law.