(571) 447-5500
Reminder that the establishment registration and product listing renewal period begins 1 October 2022.  Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October, November, or December to be ready to proceed on your schedule.

Guidance Documents of Interest

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies

​​This draft guidance will assist prospective ANDA applicants in submitting expedited safety reports of serious adverse events from certain bioavailability/ bioequivalence studies in electronic format.

Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry

This guidance describes chemistry, manufacturing, and controls postapproval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. This guidance applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

This guidance document identifies applicable legal requirements under the FD&C Act for hearing aids and for personal sound amplification products. This guidance is intended to describe hearing aids, PSAPs, their respective intended uses, and the regulatory requirements that apply to both types of products.

CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances

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

Federal Register

FR Vol. 87, No. 156 Soliciting Public Comment on Appendix A of the Food and Drug Administration’s July 2018 Guidance Entitled ‘‘Abbreviated New Drug Application Submissions—Amendments To Abbreviated New Drug Applications Under Generic Drug User Fee Amendments;’’ Notice; Establishment of a Public Docket; Request for Comments

FR Vol. 87, No. 158 Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability

FR Vol. 87, No. 158 Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids

FR Vol. 87, No. 144 Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2023

FR Vol. 87, No. 144 Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2023


Successfully Navigating the USPTO and FDA
Date: September 8, 2022
Time: 1:00 PM – 5:00 PM ET

About this Virtual Meeting

FDA, the U.S. Patent and Trademark Office (USPTO), the Silicon Valley PTO, and Biocom California will hold a free virtual meeting in which participants can hear about the intricacies that biotech and medtech independent inventors and startups face when seeking regulatory approval from the FDA and securing intellectual property rights from the USPTO. Speakers from government and industry will offer their views on current issues in this area and discuss best practices for navigating FDA and USPTO processes.

Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
Date: September 8, 2022
Time: 9:30 AM – 3:30 PM ET

2022 PDA/ FDA Joint Regulatory Conference
Date:  September 12 – 14, 2022
Day1: Mon, Sep 12 7:15 AM – 5:00 PM ET
Day2: Tue, Sep 13 7:15 AM – 5:00 PM ET
Day3: Wed, Sep 14 7:15 AM – 5:00 PM ET

The PDA/ FDA Joint Regulatory Conference. The meeting will be held Sept. 12-14 at the Renaissance Washington, DC Downtown Hotel 7:15am – 5:00PM EDT. 

***An option for remote access to the conference sessions will also be available.***

Advancing Pre-Market Safety Analytics
Date: September 14, 2022
Time: 12:00 PM – 5:00 PM ET

Advancing Generic Drug Development: Translating Science to Approval
Dates: September 20 – 21, 2022
Day1: Tue, Sep 20 8:00 AM – 5:10 PM ET
Day2: Wed, Sep 21 8:00 AM – 5:00 PM ET

Best Practices for Utilizing Modeling Approaches to Support Generic Product Development
Hosted by FDA and the Center for Research on Complex Generics (CRCG)
Workshop Times:
Day 1, Oct. 27, 2022: 8:30 a.m. – 5:00 p.m.
Day 2, Oct. 28, 2022: 8:30 a.m. – 3:40 p.m.

FREE workshop Registration.

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