Regulatory Roundup: FDA Calling on Industry to Provide Feedback on Existing Regulations
FDA Calling on Industry to Provide Feedback on Existing Regulations.
FDA announced on its Transparency Blog last week that it is calling on industry to provide feedback on existing regulations and whether any of them need improvement. The initiative is based on an
from President Obama issued this past January to improve regulation and regulatory review. Industry can provide comments through the Federal eRulemaking Portal.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
