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The FDA recently issued a warning letter to a company for inaccurate information in one of their drug listings. Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act and 21 CFR Part 207) outlines the requirements for registration and listing of drug products. EAS would like to remind our clients of the importance of ensuring not only that your drug listings are current, but also correct with regard to both product and label information. Failure to fulfill your listing obligations renders your product misbranded. If you have questions or would like further information, please contact EAS.

The Office of Global Policy and Strategy (OGPS) has launched its own Twitter account, https://twitter.com/FDA_Global. The FDA invites all to follow their new Twitter handle for day-to-day information on FDA’s global regulatory work, foreign offices and international arrangements. Have questions? Contact: FDA_Global@fda.hhs.gov.

Guidance Document updates on the FDA website

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Postmarketing Safety Reporting for Combination Products

This guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,” “final rule,” or “rule”).


Federal Register Generic Drug User Fee Rates for Fiscal Year 2020
The FDA has published the FY2020 GDUFA fee rates.

07-22-2019 FDA is announcing the withdrawal of the draft guidance for industry Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, issued in December 2016.

Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy

This guidance provides recommendations for clinical trials designed to establish clinical effectiveness and safety for hormonal drug products intended to prevent pregnancy.

Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process

This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

Using the Inactive Ingredient Database

This guidance describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products.

Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect

This guidance describes the Food and Drug Administration’s policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency.

E19 Optimisation of Safety Data Collection

This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues

This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.

Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document

The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antiviral Products (the Division) in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products.


Population Pharmacokinetics

This guidance is intended to assist sponsors of new drug applications (NDAs) and biologics license applications (BLAs) in the application of population pharmacokinetic (population PK) analysis.

Risk Evaluation and Mitigation Strategies: Modifications and Revisions

This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application holders for changes to REMS.

Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products.

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format 

This guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA).

Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations

The purpose of this guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB).

Treatment for Heart Failure: Endpoints for Drug Development

This guidance has two purposes: 1) to make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure; and 2) to provide recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

M10 Bioanalytical Method Validation 

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.

Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

This guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act.


Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials

This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.

Center for Devices and Radiological Health (CDRH) Appeals Processes

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.

Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A

This guidance document provides the Center for Devices and Radiological Health of key provisions set forth in section 517A of the Federal Food, Drug, and Cosmetic Act, as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Clinical Investigations for Prostate Tissue Ablation Devices

This draft guidance document, when finalized, will provide recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices.

Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions

This guidance document provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems.


CVM GFI #181 Blue Bird Medicated Feed Labels

The purpose of this guidance is to provide NADA sponsors of Type A medicated articles with FDA’s current thinking on the recommended content and format of Blue Bird labels.

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