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The latest developments around data security and protection signal the need for rigorous implementation of procedures and potential significant cost increases for pharma and other companies operating in China.
Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.
The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
China has introduced new rules relating to the designation and control of cancer drugs, which are being seen by some specialists as not ideal from a clinical practice perspective but positive for novel drug development.
Increasing cybersecurity reviews and the incoming Data Security Law are expected to affect companies collecting, processing and transferring data in China, and the impact is likely to go beyond its borders in relation to privacy protection and national security implications. But the health sector may be less affected than consumer services.
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency
US FDA Oncology Center of Excellence Director Rick Pazdur says PD-1/L1 drugs are very similar and hypothesizes that when competitors show differing results in the same indication it's more about trial design than the drug. FDA oncology experts also weighed in on regulatory clearance of Chinese-developed checkpoint inhibitors and trial endpoints that have come under outside scrutiny.
Facing a 40% increase in investigational new drug applications, regulatory reviewers in China are scrambling to turn down hundreds of filings plagued by major study design flaws, inconsistent samples and quality control failures.
Japan's latest batch of product approvals includes the country's second therapy for SMA and the first nod globally for a novel antidiabetic.
Confounding earlier speculation, the Fosun-Kite joint venture rather than Juno-WuXi AppTec, gains the first CAR-T cell therapy approval in China. The clearance is expected to be followed by several others in the highly active area.
As a new Delta plus variant is identified, India’s exemption of bridging trials for imported COVID-19 vaccines could help speed up immunization efforts. The urgency to fully immunize individuals could also prompt a reduction in the interval between Serum/AstraZeneca’s COVID-19 vaccine doses
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