Practical 510(k) vs PMA vs De Novo FDA Pathway Guide
Practical 510(k) vs PMA vs De Novo guidance for choosing an FDA device pathway based on classification, predicates, risk, and evidence needs
US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
US: The FDA has finalized guidance on the use of premarket pathways for combination products
The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]
FDA Finalizes Guidance for Premarket Pathways for Combination Products
The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]
New FDA guidance: Good ANDA Submission Practices
The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]
Electronic Submission Template for Medical Device 510(k) Submissions
On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which [...]
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
