We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an Aug. 6 update, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More
The FDA unveiled new draft guidance on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later this year on potentially clinically relevant outcomes. Read More
FDA Commissioner Scott Gottlieb said the agency will consider allowing imports of some drugs that have seen major price increases in the United States. Read More
The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Read More
Biosimilar sponsors need to include the name of the reference product in labeling if the label includes clinical data derived from that product, the FDA said in a final guidance. Read More
FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars and said it would help prime the “anemic” biosimilar market. Read More
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy — and Commissioner Scott Gottlieb said the agency plans to work with product sponsors to help make the development and approval of innovative gene therapies more efficient. Read More