Agency learned how to find hidden information during its investigation of Ranbaxy, with techniques including improved forensic examinations of firm computers; mock inspections held at Indian and Chinese sites ahead of FDA visits.
As FDA steps up inspections of drug manufacturing plants in India and China, companies are holding mock inspections and bringing in outside consultants and lawyers to detect problems.
Douglas Farquhar, a director at Hyman, Phelps and McNamara who has helped numerous firms prepare for inspections, said the goal...
Create an account to read this article
Already a subscriber?
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
In line with new President Lee’s campaign pledges, South Korea's newly confirmed health minister is expected to tackle key issues including a prolonged doctors' conflict, essential drug supplies and R&D support for the industry.
The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.
