The European Medicines Agency says it has been disappointing to see previously rejected applications for its PRIME scheme sent back to the agency with no additional data. On the other hand, the scheme, which is designed to get drugs for unmet medical needs to patients faster, is going from strength to strength. Kick-off meetings are identifying issues that sometime surprise companies but can be dealt with early on, well before a product is filed for authorization.
Drug developers that fail to get accepted on the European Medicines Agency’s priority medicines (PRIME) program for speeding patient access to medicines for unmet medical needs are being asked not to resubmit their application to the scheme unless they have something new to add.
“We’ve had some resubmissions” from applicants whose initial application for PRIME was rejected and “we are happy to see products...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
