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Recently Published Guidance Documents

CDER

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment

This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder. This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of such drugs.

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls

This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic analyses for biopharmaceutics applications employed by sponsors of investigational new drug applications, and applicants for new drug applications, or abbreviated new drug applications, and supplements to these applications, for oral drug product development, manufacturing changes, and controls.

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications, including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections.

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Q and A

M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk—Q and A

CDER & CBER

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

On September 24, 2019, FDA published the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy guidance. The 2019 Compliance Policy explained that the Agency intended to delay enforcement of this requirement until November 27, 2020. This guidance announces FDA’s extension of such delay in enforcement. It also sets forth the Agency’s enforcement policy, which generally provide that, beginning November 27, 2020, a dispenser must verify the product identifier of suspect or illegitimate product in the dispenser’s possession or control.

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989

This guidance is intended for applicants that are required by statute or regulation, or that have agreed in writing, to conduct postmarketing studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements or postmarketing commitments.

Premenopausal Women with Breast Cancer: Developing Drugs for Treatment

This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels, in breast cancer clinical trials.

Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

This guidance describes recommended procedures to obtain a National Drug Code for certain FDA-approved prescription drug products that are imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act. As described in further detail in the Background section of this guidance, this guidance specifically addresses FDA-approved drugs that are also authorized for sale in a foreign country in which the drugs were originally intended to be marketed

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment

This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment

This guidance provides recommendations to sponsors regarding the development of drugs and biologics, regulated by CDER and CBER for the adjuvant treatment of renal cell carcinoma. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.

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

This guidance is intended to assist applicants of abbreviated new drug applications, which were submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, in responding to complete response letters from FDA. As described in regulation, ANDA applicants are required to take action after receiving a CRL. 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.

CDRH

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

Due to the unique properties of nitinol, the Agency has developed this guidance to provide FDA’s current thinking on technical considerations specific to devices using nitinol. The recommendations in this document should be evaluated in conjunction with the intended use and technological characteristics of your device and any relevant device-specific guidances.

Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

FDA developed this draft guidance to propose select updates to FDA’s current thinking regarding the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers and fabrics that are in contact with intact skin.

Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

This guidance is being issued to address the Coronavirus Disease 2019 public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

FDA is issuing this guidance to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses, during the influenza season and for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary.

Saline, Silicone Gel, and Alternative Breast Implants

This guidance document identifies the device description, preclinical, clinical, and labeling information we recommend you present in a premarket approval application for a breast implant. This guidance document may also be useful in preparing an application for an investigational device exemption. This document addresses breast implants filled with saline, silicone gel, or alternative filler intended for breast augmentation or breast reconstruction.

Breast Implants – Certain Labeling Recommendations to Improve Patient Communication

This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this guidance to help ensure that a patient receives and understands the benefits and risks of these devices.

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications for blood glucose monitoring systems which are for prescription point-of-care use. This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types, and replaces the final guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” issued on October 11, 2016.

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications for self-monitoring blood glucose test systems which are for over-the-counter home use by lay-users. This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types and replaces the final guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” issued on October 11, 2016.

CDRH & CBER

Testing for Biotin Interference in In Vitro Diagnostic Devices

This guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing be performed, and how the results of the testing should be communicated to end-users, including clinical laboratories and clinicians.

CBER

Emergency Use Authorization for Vaccines to Prevent COVID-19

FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.

Webpages of potential interest

PDUFA VII: Fiscal Years 2023 – 2027

Developing and Manufacturing Drugs Including Biologics

Medical Device User Fee Amendments 2023 (MDUFA V)

CDRH Proposed Guidance Development

Catalog of Regulatory Science Tools to Help Assess New Medical Devices

Medical Device Development Tools (MDDT)

COVID-19 specific FDA webpages:

Personal Protective Equipment EUAs

FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection – Letter to Health Care Providers

Hand Sanitizers / COVID-19 webpage update

FDA updates on hand sanitizers consumers should not use

Posted in Drug and Device Corner.