EMA, African Medicines Agency, and African national regulators initiated joint oversight to accelerate Ebola clinical trials ...

Q5A (R2) expects sponsors to build and justify a risk-based viral safety from overlapping controls: what you prevent from ...

The transition from a breakthrough molecule to a scalable product is the industry's greatest challenge, noted Meyer. As such, ...

Artificial intelligence is shifting formulation development from empirical trial-and-error to predictive, data-driven design ...

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, ...

CMC teams can align with Q5A (R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant ...

Regulatory collaboration between EMA ETF, AMA, and African NRAs aims to enable coordinated, timely reviews, building on prior Ebola outbreak experience and AVAREF joint assessment mechanisms.

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

Data integrity, impurity characterization, and stability requirements are key focus areas in drug substance testing, with advanced analytical technologies enhancing accuracy. Newer modalities, ...

Tailored EMA and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical confirmation for ...

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with ...