USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme...
International – ICH adopts guidelines on viral safety evaluation and analytical method development
The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...
Europe – First electronic product information (ePI) published for selected human medicines
The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across...
USA – FDA finalizes guidance on real-time review of oncology drugs
The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new...
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...
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The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...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...
