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This draft guidance will assist prospective ANDA applicants in submitting expedited safety reports of serious adverse events from certain bioavailability/ bioequivalence studies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