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Certain general safety testing requirements may no longer be necessary to help ensure the safety, purity and potency of licensed biological products, the FDA said. Read More
In a widely expected move, the Drug Enforcement Administration has clamped down on misuse of hydrocodone combination products (HCPs) by classifying them as Schedule II controlled substances, a designation that already applies to oxycodone and non-combo hydrocodone painkillers. Read More
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized this week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Australian regulators are seeking industry input on the pilot phase of a new system that will let drugmakers submit applications electronically, as the country prepares to fully adopt the software next year. Read More
In an about face, a UK healthcare cost watchdog is now recommending coverage of Celgene’s blockbuster cancer drug Revlimid, persuaded by the drugmaker’s proposed payment scheme. Read More
Ferring Pharmaceuticals has won its appeal of a UK cost effectiveness watchdog’s final recommendation that would have drastically reduced the intended patient population for its cancer treatment Firmagon. Read More
Sanofi unit Genzyme says it plans to launch its new Gaucher disease therapy Cerdelga in the U.S. next month after receiving FDA approval late Tuesday. Read More
The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence.” Read More