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A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System. Read More
Joining pharma’s global transparency movement, members of a pharmaceutical association in Greece have committed to disclosing details of their financial interactions with healthcare professionals and organizations. But a loophole in such voluntary industry codes could diminish the impact of the reporting, critics say. Read More
The FDA should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More
The Therapeutic Goods Administration has adopted European Commission guidance on good pharmacovigilance practices for vaccines. The guideline includes recommendations on reporting reduced effectiveness or failure of vaccines and how to implement a recall or halt the distribution of problem batches. Read More
Drugmakers seeking to list their products on the Australian Register of Therapeutic Goods should include unfavorable nonclinical study reports in their applications, updated guidance says. Read More
The European Medicines Agency now requires centralized review of periodic safety update reports for active pharmaceutical substances found only in medicines authorized at the country level. Read More
The UK’s health cost watchdog says it is not ready to change the way it appraises medicines and other technologies, but acknowledges that further consideration is needed of how new treatments are developed, evaluated and supported for coverage. Read More