FDA
North America
August 16, 2022
FDA Issues Over-the-Counter Hearing Aids Final Rule and Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
Today, the U.S. Food and Drug Administration (FDA) issued a final rule: Establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of...
North America
IVD
August 16, 2022
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...
PDP
PMA
August 15, 2022
FDA Pathways to Medical Device Approval
Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...
CDER
FDA
August 15, 2022
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and...
ANDA
FDA
August 12, 2022
FDA Solicits Feedback on ANDA Submissions – Amendments to ANDAs Under GDUFA Guidance, Appendix A
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
FDA
North America
August 5, 2022
FDA Publishes Complex Generics News Resource
Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...
FDA
North America
August 4, 2022
FDA Recognizes August as National Immunization Awareness Month
National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The U.S....
ANDA
FDA
August 2, 2022
FDA publishes product-specific guidances to facilitate generic drug development
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...
FDA
North America
August 2, 2022
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...