FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic“. The guidance document now includes information for compounded drugs in Table 1:
|Type of Product or Application||Type of Report(s)/Statutory or Regulatory Timeframes(s)||FDA Recommended Reporting During a Pandemic With High Employee Absenteeism|
|Prescription drug products marketed without an approved New Drug Application (NDA): drugs compounded or repackaged by outsourcing facilites||15-day Alert report, 15-day Alert – follow up/15 calendar days||Submit|
Have questions on this guidance? Our experts are here to help. Fill out “Fact Check Form” for answers to this or any other health or science-related subject. Our scientific experts are committed to providing answers.
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- Antimicrobial Effectiveness | USP 795 & 797 Revisions - July 18, 2023
- 2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20 - July 11, 2023
- APC: Compounders on Capitol Hill, 09/19 – 09/20 - July 11, 2023