regulatory agency

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regulatory authority

An official body that has the power to regulate a particular activity by reviewing submitted clinical data and conducting inspections.

regulatory agency

An agency, organization or body of a federal, state or local government that creates, promulgates, and enforces rules concerning delivery of a service or product. See College of Am Pathologists, Environmental Protectional Agency, Joint Commission on Accreditation of Healthcare Organizations, OSHA–Occupational Safety and Health Administration.
References in periodicals archive ?
The accountant is the auditor of record (the accountant's report accompanied an entity's most recent annual financial statements filed with a specified regulatory agency or the accountant has been engaged to audit an entity's annual financial statements for the current period as stated in a document filed by the entity with a specified regulatory agency).
Maintaining detailed records can lessen the amount of inquiry from a regulatory agency to which the company is forced to respond.
These factors include, but are not limited to: (i) whether we will receive, and the potential timing and scope of, regulatory approvals or clearances to market CUBICIN in other countries pursuant to our currently planned filings and any filings we determine to make in the future, which filings are subject to approval by the applicable regulatory agency or agencies, regardless of our confidence in the results of the clinical trials supporting such filings; (ii)the level of acceptance of CUBICIN by physicians, patients, third party payors and the medical community; (iii)any changes in the current or anticipated market demand or medical need for CUBICIN; (iv)competition in the markets in which we and our partners market CUBICIN; (v)whether the U.
Taro," NASDAQ: TARO) reported today that Taro Pharmaceuticals (UK) Limited ("Taro UK"), its affiliate in the United Kingdom, has been granted a marketing authorization for Etopan XL Tablets 600 mg, Etodolac ("Etopan XL") by the Medicines and Healthcare Products Regulatory Agency, the UK equivalent of the U.
989MM USD in cleanup projects at generating plans in Nachi Cocom in the State of Yucatan and at Francisco Villa in the State of Chihuahua in order to meet compliance requirements from PROFEPA, the environmental policy enforcement regulatory agency of Mexico's Secretary of the Environment (SEMARNAT).

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