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The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to seek the EMA’s blessing first and get qualification or prospective advice. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
FDA Commissioner Margaret Hamburg has named Howard Sklamberg as the agency’s new deputy commissioner of global regulatory operations and policy. Read More
The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More
The FDA is encouraging drugmakers to work together to get agency qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs. Read More
The FDA is approving fewer breakthrough therapy designation requests from drugmakers and agency officials say the need for more evidence of effectiveness is the reason. Read More
A drugmaker convicted of bribery in China will have its products barred from being purchased by private and government-funded organizations for two years in the province where it is convicted. A second offense within five years will result in a two-year, nationwide ban. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More