FDA, HHS Release Regulatory Agenda for 2013
The US Department of Health and Human Services (DHHS) has released its Unified Agenda for the coming year, including dozens of final and proposed regulations set to be released by the US Food and Drug Administration (FDA).
The final list, which does not include draft or final guidance documents, which are contained in other center-specific lists, is nevertheless extensive. Many of the planned regulations are holdovers from prior lists, but several are new.
One, in particular, calls for the "Revision of postmarketing reporting requirements" for drugs experiencing a shortage situation in the case of discontinuance or supply interruptions. The changes, called for by the recently-passed FDA Safety and Innovation Act, include the definition of high-need drugs, how information about impending shortages should be distributed to stakeholders, and more.
Other new additions include new regulations regarding the review of over-the-counter cough and cold combination products and numerous food labeling requirements that would apply to nutritional and dietary supplement products.
Elsewhere in the Unified Agenda, HHS has reiterated its support for two proposed regulations aimed at enhancing research protections for clinical trials. The first, proposed by the NIH, "Expanded Registration and Results Reporting at ClinicalTrials.gov" calls for new procedures to govern the registration and reporting of results and adverse events. The second, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, announces that the Office of Human Research Protections (OHRP) is "considering revisions to the current human subjects regulations in order to strengthen protections for research subjects." The proposed regulation has been in the works for at least a year, and is in the draft stages of regulation until at least April 2013.
For a complete listing of the Unified Agenda, please visit this link. The list is maintained by the Office of Information and Regulatory Affairs (OIRA), which must approve each of the regulations individually. A condensed version of the list can be found below.
FDA | Pre-rule Stage | Over-the-Counter (OTC) Drug Review--Sunscreen Products | |
FDA | Proposed Rule Stage | Food Labeling; Revision of the Nutrition and Supplement Facts Labels | |
FDA | Proposed Rule Stage | Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed in One Eating Occasion; Dual Column Labeling; and Modifying the Reference Amounts Customarily Consumed | |
FDA | Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products | |
FDA | Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Internal Analgesic Products | |
FDA | Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products | |
FDA | Proposed Rule Stage | Laser Products; Amendment to Performance Standard | |
FDA | Proposed Rule Stage | Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals | |
FDA | Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products | |
FDA | Proposed Rule Stage | Electronic Distribution of Prescribing Information for Human Drugs Including Biological Products | |
FDA | Proposed Rule Stage | Produce Safety Regulation | |
FDA | Proposed Rule Stage | Hazard Analysis and Risk-Based Preventive Controls | |
FDA | Proposed Rule Stage | "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act | |
FDA | Proposed Rule Stage | Food Labeling; Dietary Guidance Statements | |
FDA | Proposed Rule Stage | General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps | |
FDA | Proposed Rule Stage | Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives | |
FDA | Proposed Rule Stage | Foreign Supplier Verification Program | |
FDA | Proposed Rule Stage | Accreditation of Third Parties To Conduct Food Safety Audits and for Other Related Purposes | |
FDA | Proposed Rule Stage | Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components | |
FDA | Proposed Rule Stage | Use of Symbols in Labeling | |
FDA | Proposed Rule Stage | Requirements for the Submission of Data Needed to Calculate User Fees for Manufacturers and Importers of Tobacco Products | |
FDA | Proposed Rule Stage | Food Labeling: Hard Candies and Breath Mints | |
FDA | Proposed Rule Stage | Food Labeling: Serving Sizes; Reference Amounts for Candies | |
FDA | Proposed Rule Stage | Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) | |
FDA | Proposed Rule Stage | Establishment Registration and Product Listing for Tobacco Products | |
FDA | Proposed Rule Stage | Public Information in Tobacco Marketing Applications | |
FDA | Final Rule Stage | Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors | |
FDA | Final Rule Stage | Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products | |
FDA | Final Rule Stage | Current Good Manufacturing Practice for Combination Products | |
FDA | Final Rule Stage | Postmarket Safety Reporting for Combination Products | |
FDA | Final Rule Stage | Medical Device Reporting; Electronic Submission Requirements | |
FDA | Final Rule Stage | Unique Device Identification | |
FDA | Final Rule Stage | Food Labeling: Nutrition Labeling for Food Sold in Vending Machines | |
FDA | Final Rule Stage | Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments | |
FDA | Final Rule Stage | Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products | |
FDA | Final Rule Stage | Food Labeling; Gluten-Free Labeling of Foods | |
OASH | Proposed Rule Stage | Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators | |
NIH | Proposed Rule Stage | Expanded Registration and Results Reporting at ClinicalTrials.gov |