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FDA Planning Six New Drug, Device Regulations for 2015

Posted 24 November 2014 | By Alexander Gaffney, RAC

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.


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 StageRule TitleRINStatus
ProposedSubmission of Labels and Package Inserts for Medical Devices Listed Pursuant to Section 510(j) of the Federal Food, Drug, and Cosmetic Act0910-AG79Re-Added
ProposedClarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices0910-AH19New
ProposedRevocation of the General Safety Test Regulations That Are Duplicative of Requirements in Biologic License Applications0910-AH21New
FinalAccreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications0910-AG66Re-Added
FinalBlood Initiative--Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use0910-AG87Re-Added
FinalCombinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use0910-AH16New

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 StageOver-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products0910-AF31
Proposed Rule StageOver-the-Counter (OTC) Drug Review--Internal Analgesic Products0910-AF36
Proposed Rule StageOver-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products0910-AF69
Proposed Rule StageAbbreviated New Drug Applications and 505(b)(2)0910-AF97
Proposed Rule StageCurrent Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals0910-AG10
Proposed Rule StageOver-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products0910-AG12
Proposed Rule StageElectronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products0910-AG18
Proposed Rule StageSunlamp Products; Proposed Amendment to the Performance Standard0910-AG30
Proposed Rule StageReports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals0910-AG45
Proposed Rule StageForeign Supplier Verification Program0910-AG64
Proposed Rule StageRegistration of Food Facilities: Amendments to Food Facility Registration Requirements0910-AG69
Proposed Rule StagePediatric Study Plan Requirements for New Drug and Biologics License Applications0910-AG93
Proposed Rule StageFormat and Content of Reports Intended to Demonstrate Substantial Equivalence0910-AG96
Proposed Rule StageProposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves0910-AH02
Proposed Rule StageRadiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System0910-AH03
Proposed Rule StageMammography Quality Standards Act; Regulatory Amendments0910-AH04
Proposed Rule StageInvestigational New Drug Application Annual Reporting0910-AH07
Proposed Rule StageCurrent Good Manufacturing Practice for Outsourcing Facilities0910-AH09
Proposed Rule StageRegulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act0910-AH10
Proposed Rule StageNational Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers0910-AH11
Proposed Rule StageGeneral and Plastic Surgery Devices: Sunlamp Products0910-AH14
Final Rule StageRequirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs0910-AA49
Final Rule StageContent and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling0910-AF11
Final Rule StageCombinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use0910-AF33
Final Rule StageOver-the-Counter (OTC) Drug Review--Laxative Drug Products0910-AF38
Final Rule StagePostmarket Safety Reporting for Combination Products0910-AF82
Final Rule StageLaser Products; Amendment to Performance Standard0910-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 Act0910-AG38
Final Rule StageHuman Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices0910-AG48
Final Rule StageFood Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56
Final Rule StageUse of Certain Symbols in Labeling0910-AG74
Final Rule StageRevision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)0910-AG88
Final Rule StageSupplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94
Final Rule StageVeterinary Feed Directive0910-AG95
Final Rule StageAdditions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness0910-AH08
Final Rule StageAdministrative Destruction of Certain Drugs Refused Admission to the United States0910-AH12

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