Roche’s cancer immunotherapy Tecentriq has received conditional marketing authorization under India’s layered approval process, setting the stage for a potential debut in the country. However, it remains to be seen how India’s evolving regulations in the area of clinical trial waivers could play out for such products.
A subject expert committee (SEC), which advises India’s drug regulator on trial-related permissions as part of a layered approval process, has recommended conditional marketing authorization for Roche’s anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab).
The SEC approval permits a clinical trial waiver “at this stage” for the product in view of it fulfilling “unmet...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
