REMINDER: we are at the end of the renewal period (1 Oct – 31 Dec) for medical device & drug establishment registrations, as well as drug listing certifications. Please factor holiday schedules as well as the potential of a U.S. government shutdown into your renewal timing.
EAS would like to bring to our clients’ attention, the FDA Announcement regarding a Phishing scam fraudulently using the FDA name. The current known scam is directed at food companies. We remind you to stay ever vigilant. If you receive something claiming to be from the FDA that does not come from an fda.hhs.gov domain, we advise you to immediately alert your IT department and permanently delete the communication. Never click on a link, open an attachment or forward an email from an unknown source.
On 22 Nov 2019, the FDA published the most recent batch of Product-Specific Guidances for Generic Drug Development. The batch of 105 PSGs is made up of 64 complex products; 45 products with no currently approved ANDAs, 26 of which are complex products; 78 revised PSGs; and 27 new PSGs including 5 for non-complex New Chemical Entity products and 1 for a complex NCE. While most of the revisions to this batch of PSGs are minor or editorial in nature, the FDA makes them available for feedback via comments. Please see the website for more specific information.
Guidance Document updates on the FDA website
- Transdermal and Topical Delivery Systems – Product Development and Quality Considerations This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
- Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention The purpose of this guidance is to assist sponsors in the clinical development of drugs for treatment or prevention of smallpox (variola virus) infection.
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
- Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV) infection.
CDER & CBER
- Electronic Submission of IND Safety Reports Technical Conformance Guide This document represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic.
- Providing regulatory Submissions in Electronic Format: IND Safety ReportsThis draft guidance describes the electronic format sponsors will be required to use when they electronically submit to the Food and Drug Administration (FDA or Agency) investigational new drug application (IND) safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(c)(1)(i).
CDRH & CBER
- Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.
- Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff Draft for comment purposes only
- #256 Compounding Animal Drugs from Bulk Drug Substances This draft guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals or for use as antidotes in food-producing animals under limited circumstances when no other medically appropriate treatment options exist.