FDA Planning Six New Drug, Device Regulations for 2015
The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development.
Background
The list, known as FDA's "Unified Agenda," is published bi-annually as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. While the list is intended to serve as an overview of the agency's planned actions for a given year, in practice just a small portion of the proposed regulations are finalized or even acted upon.
Several proposed rules on FDA's list have been in development for more than a decade. For example, FDA's proposed rule on antihistamine products has been in development since August 2000. A proposed rule on topical antimicrobial drug products has been in development since July 1994.
New Regulatory Proposals
Six of the proposed rules on FDA's Unified Agenda are new—three of them entirely new, and three returned to the agenda after having been removed.
| Rule Stage | Rule Title | RIN | Status |
|---|---|---|---|
| Proposed | Submission of Labels and Package Inserts for Medical Devices Listed Pursuant to Section 510(j) of the Federal Food, Drug, and Cosmetic Act | 0910-AG79 | Re-Added |
| Proposed | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices | 0910-AH19 | New |
| Proposed | Revocation of the General Safety Test Regulations That Are Duplicative of Requirements in Biologic License Applications | 0910-AH21 | New |
| Final | Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications | 0910-AG66 | Re-Added |
| Final | Blood Initiative--Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AG87 | Re-Added |
| Final | Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AH16 | New |
The newly-proposed rules would, among other things:
- Remove general safety testing (GST) requirements for biological products, which FDA considers "duplicative and obsolete," The rule was proposed in August 2014 and is set to be finalized in either late 2014 or 2015. (Link)
- Require some medical device establishments "to submit, in electronic format, the label and package insert of such certain medical devices," which FDA will then make publicly available through a "focused internet site." The rule is expected to be published in March 2015. (Link)
- Establish an OTC monograph for expectorants used with bronchodilators. The monograph is expected to be completed by July 2015. (Link)
- Finalize a rule proposed in 2007/2008 that would make donor eligibility and testing requirements "more consistent with current practices in the blood industry" while providing "flexibility to accommodate advancing technology." (Link)
- Establish regulations on how third-party auditors can audit food-producing facilities, including dietary supplement facilities. FDA anticipates final action on the rule by October 2015. (Link)
- Determine whether tobacco products should be regulated as a pharmaceutical product, medical device or a combination product. The rule is expected to be published in mid-2015. (Link)
Other Planned Regulations
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products | 0910-AF31 |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Internal Analgesic Products | 0910-AF36 |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products | 0910-AF69 |
| Proposed Rule Stage | Abbreviated New Drug Applications and 505(b)(2) | 0910-AF97 |
| Proposed Rule Stage | Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals | 0910-AG10 |
| Proposed Rule Stage | Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products | 0910-AG12 |
| Proposed Rule Stage | Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products | 0910-AG18 |
| Proposed Rule Stage | Sunlamp Products; Proposed Amendment to the Performance Standard | 0910-AG30 |
| Proposed Rule Stage | Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals | 0910-AG45 |
| Proposed Rule Stage | Foreign Supplier Verification Program | 0910-AG64 |
| Proposed Rule Stage | Registration of Food Facilities: Amendments to Food Facility Registration Requirements | 0910-AG69 |
| Proposed Rule Stage | Pediatric Study Plan Requirements for New Drug and Biologics License Applications | 0910-AG93 |
| Proposed Rule Stage | Format and Content of Reports Intended to Demonstrate Substantial Equivalence | 0910-AG96 |
| Proposed Rule Stage | Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves | 0910-AH02 |
| Proposed Rule Stage | Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System | 0910-AH03 |
| Proposed Rule Stage | Mammography Quality Standards Act; Regulatory Amendments | 0910-AH04 |
| Proposed Rule Stage | Investigational New Drug Application Annual Reporting | 0910-AH07 |
| Proposed Rule Stage | Current Good Manufacturing Practice for Outsourcing Facilities | 0910-AH09 |
| Proposed Rule Stage | Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act | 0910-AH10 |
| Proposed Rule Stage | National Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers | 0910-AH11 |
| Proposed Rule Stage | General and Plastic Surgery Devices: Sunlamp Products | 0910-AH14 |
| Final Rule Stage | Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | 0910-AA49 |
| Final Rule Stage | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling | 0910-AF11 |
| Final Rule Stage | Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use | 0910-AF33 |
| Final Rule Stage | Over-the-Counter (OTC) Drug Review--Laxative Drug Products | 0910-AF38 |
| Final Rule Stage | Postmarket Safety Reporting for Combination Products | 0910-AF82 |
| Final Rule Stage | Laser Products; Amendment to Performance Standard | 0910-AF87 |
| Final Rule Stage | "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act | 0910-AG38 |
| Final Rule Stage | Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices | 0910-AG48 |
| Final Rule Stage | Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines | 0910-AG56 |
| Final Rule Stage | Use of Certain Symbols in Labeling | 0910-AG74 |
| Final Rule Stage | Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages) | 0910-AG88 |
| Final Rule Stage | Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products | 0910-AG94 |
| Final Rule Stage | Veterinary Feed Directive | 0910-AG95 |
| Final Rule Stage | Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | 0910-AH08 |
| Final Rule Stage | Administrative Destruction of Certain Drugs Refused Admission to the United States | 0910-AH12 |