Regulatory Focus™ > News Articles > FDA Releases Updated Regulatory Agenda, Detailing 15 New Areas of Interest

FDA Releases Updated Regulatory Agenda, Detailing 15 New Areas of Interest

Posted 08 July 2013 | By Alexander Gaffney, RAC 

The US Department of Health and Human Services (DHHS) has released its updated Unified Agenda for the remainder of 2013, 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, includes many holdovers from prior lists, but several newly-announced regulations as well.

The list includes 15 regulations that were not on the agency's more recent prior list:

Status

Rule Stage

Regulation Title

Description

Link

NEW

Prerule

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures

FDA is currently reviewing regulations promulgated under the Prescription Drug Marketing Act (PDMA). FDA is undertaking this review to determine whether the regulations should be changed or rescinded to minimize adverse impacts on a substantial number of small entities. FDA has extended again the completion date by 1 year and will complete the review by November 2013. 

0910-AG14

NEW

Proposed

Abbreviated New Drug Applications and 505(b)(2) Applications

This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and 505(b)(2) applications relating to patent certifications, provision of notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements and the types of bioavailability and bioequivalence data that can be used to support these applications. 

0910-AF97

NEW

Proposed

Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Second Phase

FDA will revise regulations for "current good manufacturing practice" for oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products. This revision will update and harmonize requirements and improve detection and response to emerging product safety and quality signals. 

0910-AG20

NEW

Proposed

Sunlamp Products; Proposed Amendment to the Performance Standard

FDA plans to update the performance standard for sunlamp products to improve safety, reflect new scientific information, and work towards harmonization with international standards. For example, incorporating specific elements of the International Electrotechnical Commission's standard by reference would allow the agency to take advantage of the expertise of the international committees involved in the modernization of the international standard, and thus save agency resources. FDA also plans to include changes to the required warning label.

0910-AG30

NEW

Proposed

Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals

Section 105 of the Animal Drug User Fee Amendments of 2008 amended the Federal Food, Drug, and Cosmetic Act to require that the sponsor of each antimicrobial new animal drug product submit an annual report to the Food and Drug Administration on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data. 

0910-AG45

NEW

Proposed

Establishing 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 Act

FDA is proposing regulations to establish a list of "qualifying pathogens" that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is designed to encourage development of new antibacterial and antifungal drugs, and provides incentives such as fast-track status and new exclusivity periods. The preamble to the proposed rule describes the factors considered and methodology used to develop this list of qualifying pathogens. 

0910-AG92

NEW

Proposed

Pediatric Study Plan Requirements for New Drug and Biologics License Applications

FDA is proposing regulations to establish requirements for pediatric study plans. The proposed rule would implement section 506 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is designed to facilitate pediatric product development. The proposed rule would require the submission of pediatric study plans earlier in the drug development process than currently occurs in many cases. FDA is also proposing requirements for the content of initial pediatric study plans, a process for reaching agreement with FDA on initial plans, and a process for amending pediatric study plans. 

0910-AG93

NEW

Proposed

Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change. The proposed rule would describe the process by which information regarding a "changes being effected" (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder's CBE labeling supplement. These proposed revisions to FDA's regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements. 

0910-AG94

NEW

Proposed

Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves

FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present a substantial risk of illness that cannot be corrected by a change in labeling. These gloves are Powdered Natural Rubber Latex Surgeon's Gloves, Powdered Synthetic Latex Surgeon's Gloves, Powdered Natural Rubber Latex Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Consequently, FDA is proposing to ban these devices. 

0910-AH02

NEW

Proposed

Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

The proposed rule would establish special controls for the computed tomography (CT) x-ray system, a class II device as defined in 21 CFR 892.1750. A CT x-ray system is a diagnostic x-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, or, in extremely high doses, radiation poisoning. Therefore, the design of a CT x-ray system needs to balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing special controls, combined with the general controls, to provide reasonable assurance of the safety and effectiveness of a class II CT x-ray system. 

0910-AH03

NEW

Proposed

Mammography Quality Standards Act; Regulatory Amendments

FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes, such as breast density reporting, that have occurred since the regulations were published in 1997. 

0910-AH04

NEW

Final

Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling

This final rule will amend the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of regulations regarding the labeling for human prescription drug and biological products (21 CFR 201.56 and 201.57) to better communicate risks. 

0910-AF11

NEW

Final

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and ICH standards for the electronic submission of safety information. 

0910-AF96

NEW

Final

Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure

The regulation would amend 21 CFR 814 to require applicants who submit premarket approval applications or a supplement to an application, product development protocols, and applications for humanitarian device exemptions to include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected patients. This rule would not require additional clinical research and simply requires the applicant to briefly summarize readily available information. 

0910-AG29

NEW

Final

Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements

This final rule will adopt FDA's interim final rule that amended the regulation on record availability requirements, including expansion of FDA records access. 

0910-AG73

Prerule

Over-the-Counter (OTC) Drug Review--Sunscreen Products

 

0910-AF43

Proposed

Food Labeling; Revision of the Nutrition and Supplement Facts Labels

 

0910-AF22

Proposed

Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products

 

0910-AF31

Proposed

Over-the-Counter (OTC) Drug Review--Internal Analgesic Products

 

0910-AF36

Proposed

Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products

 

0910-AF69

Proposed

Laser Products; Proposed Amendment to Performance Standard

 

0910-AF87

Proposed

Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products

 

0910-AG12

Proposed

Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products

 

0910-AG18

Proposed

Hazard Analysis and Risk-Based Preventive Controls

 

0910-AG36

Proposed

Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals--Components

 

0910-AG70

Proposed

Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)

 

0910-AG88

Final

Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products

 

0910-AF33

Final

Postmarket Safety Reporting for Combination Products

 

0910-AF82

Final

Medical Device Reporting; Electronic Submission Requirements

 

0910-AF86

Final

Unique Device Identification

 

0910-AG31

Final

Use of Certain Symbols in Labeling

 

0910-AG74



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