In this week’s news, FDA clarifies generics review process, EU relaxes rules to try and stop post Brexit disruption and more…
US FDA finalizes guidelines for “controlled correspondence” for generics
The US FDA has clarified rules on how it will handle correspondence from generics firms with drugs under review.
The US regulator made the clarification in final guidance issued last week.
It said the document “provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development.”
“Controlled correspondence” is defined as requests for information related to involve the evaluation of clinical content or the review of bioequivalence (BE) protocols for drugs that reference listed drugs.
The agency also specifies that correspondence is submitted through the CDER portal https://edm.fda.gov/.
EMA says firms with drugs that ref UK sites must prep for Brexit
A “large number” of centrally authorized products (CAPs) reference UK sites and activities that need to be removed after Brexit according to the EMA.
The agency flagged the issue in a recent webinar explaining, in addition to sites, UK-based representative listed in CAPs will need to be replaced by people based in the European Economic Area or Northern Ireland.
The EMA also said it has started to allow firms with UK authorized products to change the country code in their authorizations. The agency wants EMA wants all those containing the term “United Kingdom (Northern Ireland)” to be updated by the end of the year.