Regulatory Focus™ > News Articles > Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

Posted 27 May 2014 | By Alexander Gaffney, RAC

Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014.

DQSA-Related Rules

Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue proposed rules related to good manufacturing practices at outsourcing facilities (planned release: November 2014), and drug compounding differences between 503A and 503B facilities (planned release: October 2014).

Another DQSA regulation is an FDA proposal to make it easier to destroy low-value drugs that are refused admission into the US, such as those believed to be counterfeit or adulterated. That proposal was released in May 2014.

Yet another DQSA regulatory proposal would establish national standards for licensing prescription drug wholesale distributors and third-party logistics providers, and would also set up a federal licensing system to be used in the event that a state system does not meet federal standards. The proposal is set to be released in November 2013, with the final rule due no later than November 2015.

A fifth proposed rule would establish a list of drug products that would not be able to be compounded by a pharmacy by virtue of their having been removed or withdrawn from the market for reasons of safety or efficacy, either in whole or in part. That proposed rule is set to be released by the end of May 2014.

Non-DQSA Rule Proposals

Two rules appear to be unrelated to the DQSA, however.

One would "revise the requirements concerning annual reports submitted to investigational new drug applications (INDs) by replacing the current annual reporting requirement" with one endorsed by the International Conference on Harmonisation (ICH), similar to what FDA has done with ICH's E2C postmarket reporting standard. (Planned release date: March 2015)

The second proposed rule would restrict tanning beds and tanning lamps, though FDA did not elaborate on the broader intent of the rule. FDA has previously called for new labeling requirements for tanning beds, though this proposed rule appears to be different than that proposal.

Rule StageRule TitleRINNew Rule?
Proposed Rule StageInvestigational New Drug Application Annual Reporting0910-AH07NEW
Proposed 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-AH08NEW
Proposed Rule StageCurrent Good Manufacturing Practice for Outsourcing Facilities0910-AH09NEW
Proposed Rule StageRegulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act0910-AH10NEW
Proposed Rule StageNational Standards for Licensing of Prescription Drug Wholesale Distributor and Third-Party Logistics Providers0910-AH11NEW
Proposed Rule StageAdministrative Destruction of Certain Drugs Refused Admission to the United States0910-AH12NEW
Proposed Rule StageGeneral and Plastic Surgery Devices: Restriction of Sunlamp Products0910-AH14NEW
Prerule StageFDA Food Safety Modernization Act (FSMA) Amendments to Reportable Food Registry (RFR Requirements)0910-AG97NEW
Proposed Rule StageFood Labeling; Revision of the Nutrition and Supplement Facts Labels0910-AF22-
Proposed Rule StageFood Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs0910-AF23-
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--Oral Health Care Products0910-AF40-
Proposed Rule StageOver-the-Counter (OTC) Drug Review--Sunscreen Products0910-AF43-
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 StageUpdated Standards for Labeling of Pet Food0910-AG09-
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 StageProduce Safety Regulation0910-AG35-
Proposed Rule StageCurrent Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food0910-AG36-
Proposed 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-
Proposed Rule StageReports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals0910-AG45-
Proposed Rule StageRequirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives0910-AG59-
Proposed Rule StageForeign Supplier Verification Program0910-AG64-
Proposed Rule StageRegistration of Food Facilities: Amendments to Food Facility Registration Requirements0910-AG69-
Proposed Rule StageEstablishment Registration and Product Listing for Tobacco Products0910-AG89-
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 StageSanitary Transportation of Human and Animal Food0910-AG98-
Proposed Rule StageFood Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods0910-AH00-
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 Tobacco Product Applications and General Information Regarding Submission of Information to Support Legal Marketing0910-AH06-
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 Decongestants or Expectorants; 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 StagePostmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements0910-AF96-
Final Rule StageHuman Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices0910-AG48-
Final Rule StageFood Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56-
Final Rule StageFood Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-AG57-
Final Rule StageUse of Certain Symbols in Labeling0910-AG74-
Final Rule StageRequirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products0910-AG81-
Final Rule StageRevision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)0910-AG88-
Final Rule StageEstablishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health Under the Food and Drug Administration Safety and Innovation Act0910-AG92-
Final Rule StageSupplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94-
Final Rule StageVeterinary Feed Directive0910-AG95-

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