The government has expedited the drug approval process by allowing immediate laboratory testing post-application, bypassing preliminary scrutiny. The Central Drugs Standard Control Organization's new ...
Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.
FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...
AI could review data sets to assist clinical scientists ...
For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...
Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...
The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...
CDSCO will permit drugmakers to begin testing samples as soon as applications are filed, shifting detailed scrutiny to later ...
India's drug regulator Central Drugs Standard Control Organization has revised testing permission norms to speed up approvals. From June 1, 2026, companies can start lab testing immediately after ...