FDA Rules definition

FDA Rules means all FDA rules, regulations and guidances as amended from time to time.
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FDA Rules means any and all applicable laws, statutes, rules, regulations, standards, policies, orders or other requirements promulgated or subject to enforcement, regulation or administration by the United States Food and Drug Administration (the “FDA”), all as amended or modified from time to time, and includes, but is not limited to, current Good Manufacturing Practice regulations of the FDA as set forth in Title 21 of the U.S. Code of Federal Regulations §§ 210 and 211 (“cGMPs”). CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS ([***]) DENOTE SUCH OMISSIONS. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMMITTED INFORMATION.
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FDA Rules is defined in Section 5.12.1.
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Examples of FDA Rules in a sentence

  • Karst, FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks to be Sued, FDA LAW BLOG (Mar.

  • See, e.g., FDA, Rules, Regulations and Guidance, https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and- guidance (last visited July 18, 2021) (describing industry guidance as informing the tobacco industry of “pathways to legally market new tobacco products”).

  • All devices, instruments, and epilators shall conform to the Federal FDA Rules and Regulations relating to such devices as amended, May 29, 1976 and shall be FCC approved.

  • When such FDA Rules are promulgated, the plaintiffs will be allowed to ask the court to reopen the proceeding.

  • All devices, instruments, and epilators, shall conform to the Federal FDA Rules and Regulations relating to such devices as amended, May 29, 1976, and shall be FCC approved.

  • Only FCC approved types of epilators which conform to the Federal FDA Rules and Regulations shall be used by each school in training students.

  • Each exhibitor is solely responsible for compliance with FDA Rules and Regulations which address the labeling of displayed products and for determining if a product may be promoted for a use that is generally accepted among oncologists or other medical professionals and for which FDA approval is not required.

  • Only FCC approved types of epilators which conform to the Federal Food and Drug Administration (FDA) Rules and Regulations shall be used by each apprenticeship program in training apprentices.

  • By Peter Nelson, Solicitor(Settlement Agreement with the Montgomery County Board of Assessment)This is a tax assessment appeal between the School District and the camp owners for Global Youth Foundation and Hope for Kids, but the Township has to agree to the settlement as well.

  • Such records shall comply with all FDA Rules and shall identify the Consignee of the food Shipment; the origin and destination points of the Shipment; the date the Shipment is received and the date released; the number of Parcels in the Shipment; a description of the freight including the type of food received and delivered; and the route of movement.


More Definitions of FDA Rules

FDA Rules shall have the meaning assigned to that term in Section 4.24 hereof.
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Related to FDA Rules

  • M&A Rules means the Provisions on Merging and Acquiring Domestic Enterprises by Foreign Investors, which was promulgated by six Governmental Agencies, namely, the Ministry of Commerce, the State-owned Assets Supervision and Administration Commission, the State Administration for Taxation, the State Administration for Industry and Commerce, the China Securities Regulatory Commission (the “CSRC”), and the State Administration of Foreign Exchange, on August 8, 2006 and became effective on September 8, 2006, as amended by the Ministry of Commerce on June 22, 2009.

  • PRA Rules means the Rules included within the PRA handbook issued by the PRA.

  • FCA Rules means the Rules included within the FCA Handbook issued by the FCA.

  • HIPAA Rules means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.

  • PPB Rules means the rules of the Procurement Policy Board as set forth in Title 9 of the Rules of the City of New York (“RCNY”), § 1-01 et seq.

  • FSA Rules meanss the rules, guidance, principles and codes comprised in the Handbook of Rules and Guidance issued by the FSA. The parties understand and agree that such categorisation is not intended to, and does not, affect the relationship between and among the parties under the 1940 Act or the Advisers Act.

  • AIM Rules means the rules published by the London Stock Exchange governing admission to AIM and the regulation of AIM companies as amended or re-issued from time to time;

  • Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.

  • JAMS Rules has the meaning assigned thereto in Section 13 hereof.

  • Site Rules means all rules, regulations, directives and policies notified by the Company from time to time which are intended to be of general application to persons at a Site controlled or managed by the Company.

  • HKIAC Rules shall have the meaning ascribed to it in Section 10.13(a).

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • Hague-Visby Rules means the provisions of the International Convention for the Unification of certain rules Relating to Bills of Lading signed at Brussels on 25th August 1924 as amended by the Visby Protocol of 23rd February 1968 and the SDR Protocol of 21st December 1979;

  • Scheme Rules means the applicable SEPA direct debit or credit transfer scheme rules of the European Payments Council as amended from time to time.

  • Market Rules means the rules made under section 32 of the Electricity Act;

  • Business Rules means the business rules established by JSCC regarding its Financial Instruments Obligation Assumption Service for CDS Transactions, as amended, if applicable.

  • ISO-NE Rules means all rules and procedures adopted by NEPOOL, ISO-NE, or the RTO, and governing wholesale power markets and transmission in New England, as such rules may be amended from time to time, including but not limited to, the ISO-NE Tariff, the ISO-NE Operating Procedures (as defined in the ISO-NE Tariff), the ISO-NE Planning Procedures (as defined in the ISO-NE Tariff), the Transmission Operating Agreement (as defined in the ISO-NE Tariff), the ISO-NE Participants Agreement, the manuals, procedures and business process documents published by ISO-NE via its web site and/or by its e-mail distribution to appropriate NEPOOL participants and/or NEPOOL committees, as amended, superseded or restated from time to time.

  • AAA Rules has the meaning set forth in Section 11.2.

  • SIFT Rules means the provisions of the Tax Act, including those contained in sections 104, 122 and 122.1 of the Tax Act, which apply to the taxation of a “specified investment flow through trust” and its unitholders.

  • the Rules means the Insolvency Rules 1986 (as amended);

  • Hague Rules means the International Convention for the Unification of certain Rules of Law relating to Bills of Lading signed at Brussels on 25 August 1924.

  • QFC Stay Rules means the regulations codified at 12 C.F.R. 252.2, 252.81–8, 12 C.F.R. 382.1-7 and 12 C.F.R. 47.1-8, which, subject to limited exceptions, require an express recognition of the stay-and-transfer powers of the FDIC under the Federal Deposit Insurance Act and the Orderly Liquidation Authority under Title II of the Xxxx Xxxxx Wall Street Reform and Consumer Protection Act and the override of default rights related directly or indirectly to the entry of an affiliate into certain insolvency proceedings and any restrictions on the transfer of any covered affiliate credit enhancements.