How to comment on FDA regulations
Recommendation
20/21 December 2022
How to pass global GMP Inspections
Register now for ECA's GMP Newsletter
The FDA regularly issues drafts of guidances. What most people do not know is that anyone may comment on these drafts. Normally, the FDA also allows the public enough time to do so.
When the FDA publishes a new guidance or revises an existing one, it announces its intention in the Federal Register. This is also accessible on the internet. As soon as the announcement is published, the period for comments begins.
The procedure is described in detail on the page How to Use Regulations.gov. It explains how to search for documents.
Comments are typically submitted online. People can do this on the page Comment on Proposed Regulations and Submit Petitions. A variety of search options lead to the document required. The direct link to the relevant section of the Federal Register is also located here. People who want to submit comments must follow the instructions to the letter.
Related GMP News
23/11/2022
20/09/2022
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others