(571) 447-5500

EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504.

The FDA has finalized the UDI draft guidance document originally published 14 October 2021, which will supersede the guidance issued on 1 July 2020. Federal Register Vol. 87, No. 141 “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices; Guidance for Industry and Food and Drug Administration Staff; Availability” announced this publication. (yes, that is all one title!)

Of particular note, the agency has finalized their enforcement discretion decision of the requirement for UDI information submission to the GUDID database of “Consumer Health Products” (CHP). FDA reviewed available information such as recalls and medical device reports for a better understanding on whether submission of CHP data to the GUDID system would benefit the public. At this point in time, the agency does not feel UDI information for CHP is needed to improve device safety. The finalized guidance document also gives further clarification on which medical devices the agency considers CHP for the purposes of this policy. If a labeler has questions regarding whether their device is considered a consumer health product that is within the scope of this compliance policy, the labeler may contact the FDA at GUDIDSupport@fda.hhs.gov.

The guidance also reiterates the FDA’s existing compliance policy re direct marking of relevant medical devices that were manufactured prior to 24 September 2022. Please see the FR notice and guidance document for full details.

It’s never too early to begin planning for the annual establishment registration renewal and listing certification process which takes place October – December. Remember to factor in holiday schedules toward the end of the year. If you would like EAS to handle your establishment registration renewal and/or listing certification, please contact Victoria Pankovich, vpankovich@easconsultinggroup.com. We can set up an appointment in October, November, or December to be ready to proceed on your schedule.

The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted would require the addition of the 11 digit format when 5 digit labeler codes are no longer available. The new 12 digit format would consist of a 6 digit labeler code, a 4 digit product code, and a 2 digit package code. The agency’s plan is to automatically update existing 10 digit codes by adding a leading zero to the necessary fields. For example, NDC 12345-678-90 would be converted to 012345-0678-90. FDA would make these adjustments in their system after the implementation date for existing NDC’s to alleviate the burden on registrants to do so.

The proposed effective date is 5 years from publication of the final rule, with a 3 year transition period following the effective date during which both the 10 digit and 12 digit NDCs will be considered valid. This should allow industry enough time to utilize existing labels prior to implementation of the new 12 digit format.

FDA also looked at the impact on other health agencies which utilize/reference the drug product NDC number. The agency has proposed to revise the regulation to allow for not only linear and nonlinear barcodes, but also allowing for unspecified formats that advances in technology may develop in future. See the Federal Register and Proposed rule for full details.

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use in the FR Vol. 87, No. 123. Comments can be submitted to Docket ID: FDA-2021-N-0862 by 26 October 2022. This proposed rule seeks to establish requirements for nonprescription drug products which have “additional condition for nonprescription use” (ACNU). Under the proposed rule, applicants would present to the FDA via an NDA or ANDA, additional conditions that a consumer must successfully fulfill to obtain the nonprescription drug product. These NDA/ANDA must be new applications separate from an existing NDA/ANDA; not submitted as a supplement to an already approved application, or amendment to a currently pending application. The FDA sees a benefit to have both prescription and nonprescription ACNU marketing of the same drug. Their rational can be found in the proposed rule.

There are 7 ACNU specific requirements for an NDA/ANDA submission in addition to existing criteria. The proposal also includes specific postmarketing reports, and additional labeling requirements which will support safe use of these nonprescription ACNU drug products. The agency does not have specific requirements on how the ACNU should be implemented.

Associated Guidance Documents

Self-Selection Studies for Nonprescription Drug Products

This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product.

Innovative Approaches for Nonprescription Drug Products

This guidance describes two innovative approaches that may be useful to consider for demonstrating safety and effectiveness for a nonprescription drug product in cases where the drug facts labeling alone is not sufficient to ensure that the drug product can be used safely and effectively in a nonprescription setting: (1) the development of labeling in addition to the DFL, and (2) the implementation of additional conditions so that consumers appropriately self-select and use the product.

Guidance Documents of Interest

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry

This guidance is intended to assist applicants of abbreviated new drug applications, which were submitted under section 505(j) of the FD&C Act, in responding to complete response letters from FDA. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that FDA may take if the applicant fails to respond to that CRL.

Orange Book Questions and Answers Guidance for Industry

This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). This guidance provides answers to commonly asked questions that we have received from these interested parties regarding the Orange Book.

Considerations for Rescinding Breakthrough Therapy Designation

This guidance explains how, during its evaluation of a drug development program, FDA may consider whether to rescind a breakthrough therapy designation.

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

This guidance provides recommendations for developing the content and format of a patient Instructions for Use document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application or a biologics license application.

Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”

This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application submitted under the FD & C Act, a biologics license application submitted under the Public Health Service Act, or a supplement to one of these approved applications when an applicant proposes to develop ready-to-use containers with a range of different strengths and seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing information of a previously approved drug product that is based on weight or body surface area.

Evaluation of Therapeutic Equivalence

The draft guidance explains the criteria FDA

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments

This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development guidance documents that describe how stakeholders (patients, caregivers, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. When finalized, Guidance 3 will represent the current thinking of CDER, CBER, and CDRH on this topic.

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

This guidance describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with compounds containing a beta-lactam ring. This guidance recommends complete and comprehensive separation of the manufacturing operations of non-penicillin beta-lactam antibacterial drugs from the manufacturing operations of other drugs. For manufacturers of non-antibacterial beta-lactam compounds, this guidance provides recommendations on cross-contamination prevention strategies, including examples of relevant design features and control approaches for those seeking to justify a cross-contamination prevention strategy other than complete and comprehensive separation when appropriate.

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs

This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards.

Identifying Trading Partners Under the Drug Supply Chain Security Act

The Food and Drug Administration is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act. Uses to evaluate the therapeutic equivalence of drug products and what the TE codes indicate.

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

This guidance is intended to assist sponsors of investigational new drug applications and applicants of new drug applications, biologics license applications, and supplements to such applications who are planning to conduct clinical studies in neonatal populations.

Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations

This draft guidance recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices.

All Guidance Documents can be searched on the FDA’s website.


Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

Date: August 10, 2022
Time: 1:00 PM – 2:30 PM ET

Best Practices for Topical Generic Product Development and ANDA Submission webinar

Date: August 11, 2022
Time: 9:30 AM – 12:30 PM ET

2022 FDA CVM Advanced Manufacturing Public Meeting

Date: August 11, 2022
Time: 1:00 PM – 4:00 PM ET

Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines

Dates: August 16 – 18, 2022
Day1: Tue, Aug 16 8:30 AM – 12:30 PM ET
Day2: Wed, Aug 17 8:30 AM – 12:30 PM ET
Day3: Thu, Aug 18 8:30 AM – 12:30 PM ET

FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs

Date: September 19, 2022
Time: 9:00 AM – 4:00 PM ET

Posted in Drug and Device Corner, Drugs, Medical Devices.