Commissioner Gottlieb stands pat (actually he was sitting) during hearing where lawmakers suggest FDA has gone overboard in implementing DQSA. And while he acknowledges that '503 lite' isn't the best term to use, Gottlieb says agency’s plan to create different risk tiers for drug outsourcing pharmacies offers the flexibility that can entice more traditional pharmacies to register as outsourcing centers, and thus be subject to GMP oversight.
The US FDA was admonished Jan. 30 by a score of lawmakers who argued that banning the practice of compounding drugs for office use and creating different risk tiers for drug outsourcing pharmacies to entice more traditional pharmacies to register are bad policies that could have negative implications for the public health.
But Commissioner Scott Gottlieb stood his ground during the hearing by House Energy and Commerce Subcommittee on Health, saying that...
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
