An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to…
FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World…
Drug sponsors can prove the effectiveness of combination drugs for treatment of hypertension with trials that test the highest approved dosage rather than trials with multiple doses, the FDA said…
China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced…
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Source: International Pharmaceutical Regulatory Monitor
Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued…
Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making…
The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent…
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug…