UK – MHRA authorises enzyme inhibitor Anastrozole to prevent breast cancer in post-menopausal women

The Medicines and Healthcare products Regulatory Agency (MHRA) has today authorised this new indication for Anastrozole, a hormone treatment used for breast cancer in...

USA – FDA publishes two guidances on collecting clinical outcomes data

The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The...

USA – FDA moving in the right direction with psychedelic drug guidance

The US Food and Drug Administration’s (FDA) recent guidance on psychedelic drug development is a “policy landmark” and a step in the right direction...
Coronavirus delays many FDA foreign inspections

USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas

The US Food and Drug Administration (FDA) is ramping up its monitoring of firms in areas of the world considered high risk for manufacturing...

USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...

USA – FDA won’t extend LDT rule comment period

The US Food and Drug Administration (FDA) will not extend the comment period deadline for a proposed rule that would start phasing out its...

Europe – EMA encourages companies to submit type I variations for 2023 in November...

EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to...

USA – FDA expands KASA review program to drug substances

The US Food and Drug Administration (FDA) is now piloting its Knowledge-aided Assessment and Structured Application (KASA) drug review program for drug substances as...

Europe – EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5

EMA’s human medicines committee (CHMP) has recommended authorising an adapted Nuvaxovid vaccine targeting the Omicron XBB.1.5 subvariant of the SARS-CoV-2 virus. The vaccine, known as Nuvaxovid XBB.1.5, is to...

USA – FDA expands scope of off-label guidance to include presentations from reprints

The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...