USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
USA – FDA issues 80 guidances for topical products
The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or...
USA – FDA finalizes multiple endpoints guidance
The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs
The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII)...
Europe – EMA recommends approval of second adapted Spikevax vaccine
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the...
Europe – EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from...
EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including...
UK – Grifols’ Tavlesse receives NICE recommendation
Therapy treats refractory chronic immune thrombocytopenia and is available across UK.
Grifols has announced that its treatment for adults with chronic immune thrombocytopenia (ITP), Tavlesse...
USA – Pharma industry making some headway in DSCSA implementation
The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA),...
USA – Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes
The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval...
