EAS would like to remind all DMF holders that the FDA DEADLINE for eCTD submissions is fast approaching. As of 5 May 2018, the FDA will only accept eCTD submissions to ALL DMF files. If you have not already made plans for conversion, you should do so immediately. If you have any questions, feel free to contact EAS. While on the topic of DMFs Albert Yehaskel, EAS Independent Advisor for Pharmaceutical Submissions, has written a very informative white paper, “An Overview of Drug Master Files”. This has been slightly updated and added to our website, please use this link to access this valuable resource.
The Food and Drug Administration is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. Submit either electronic or written comment by February 21, 2018.
In the event you missed the FDA announcement, the agency has created a new platform to request pre-ANDA meetings. This platform, CDER Direct NextGen Collaboration Portal, was designed to help the FDA minimize manual data entry and support the agency’s GDUFA II performance goals. The new technology platform, which will allow the industry to request pre-ANDA meetings for complex generic drug products with the FDA. In just a few steps, potential applicants of abbreviated new drug applications (ANDAs) will be able to initiate requests by uploading a meeting request package. The portal also allows the industry to submit supporting documents, such as meeting presentation materials, requests for additional information made by the FDA, and post-meeting comments. For additional information about the portal, please visit the FDA Pre-ANDA Program webpage.
FDA (or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs, and certain INDs to CBER and CDER. The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after the publication of the final guidance “Providing Regulatory Submissions in Electronic Format–Standardized Study” in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates is published. When future new study data standards are listed in the Catalog, these new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing such new standards is published. Please see the FDA Study Data Standards Resources webpage for further information.
Guidance Document updates on the FDA website: CDER:
- Good ANDA Submission Practices
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
- Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved biologics License Application
- Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders
- Labeling for Combined Hormonal Contraceptives
- Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)
- Unique Device Identification – Policy Regarding Compliance Dates for Class I and Unclassified Devices
- Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV) – Testing, Product Disposition, and Donor Deferral and Reentry