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Drugmakers operating in New Zealand must begin creating safety signal management processes for every drug they distribute to satisfy the country’s drug regulators. Read More
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to Wednesday guidance that sets specific timelines for every step of the dispute resolution process. Read More
The FDA is giving industry and other interested parties another 30 days to weigh in on its request for suggestions on new biomarkers to speed drug development, according to an FDA notice. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
Makers of branded opioid pain relievers that want to claim their drugs are resistant to abuse must, in most cases, subject their products to three forms of tests to show the FDA how effectively they prevent misuse. Read More
Generics makers may soon have a new way to challenge first-filer marketing exclusivity held by their rivals under certain circumstances after a federal appeals court reinstated a lawsuit from Apotex. Read More
The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
Mylan is recalling two injectables — a hypertension drug and cancer treatment — due to quality control issues. Both drugs were manufactured in India. Read More
The U.S. government has awarded BioCryst $12.1 million for further development of its BCX4430 antiviral that targets multiple pathogens — including Ebola. Read More
Drugmakers in the European Union will pay slightly lower fees starting today, under an annual adjustment that reflects the inflation rate for the previous year. Read More