Department of Health and Human Services March 29, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
The Food and Drug Administration (FDA) is proposing to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act (the act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA is also proposing, as directed by FDAAA, standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.
Privacy Act of 1974; Report of an Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Health Professions Planning and Evaluation (SORN 09-15-0046; 63FR14124).
Veterinary Feed Directive
The Food and Drug Administration (FDA or the agency) is announcing an advance notice of proposed rulemaking (ANPRM) to solicit comments from the public regarding potential changes to its current regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is undertaking a review of these requirements in an effort to identify possible changes to improve efficiency. Therefore, the agency is requesting public comment on all aspects of the VFD regulation, particularly suggestions relating to improving efficiency. This information may be used to help draft a proposed rule in the near future.
Food and Drug Administration/Xavier University Global Medical Device Conference
The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials, global regulators, and industry experts. The public conference has three separate tracks of interest for quality, regulatory affairs, and clinical research professionals, and is intended for companies of all sizes and employees at all levels.
Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages.'' This guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standards for standardized numerical identifiers for prescription drugs.
Advisory Committees; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. FDA is
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