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An FDA official is taking steps to clarify labeling requirements for generic drugmakers, as frequent deficiencies can lead to increased review cycles and labeling that differs from reference products. Read More
The FDA is proposing to extend review times to enable more communication between the agency and sponsors to increase the number of first cycle approvals for biosimilars. Read More
Generic drug applicants need to get their bioanalytics right when demonstrating bioequivalence to avoid costly delays or outright rejection by the FDA, an agency official warns. Read More
The Office of Generic Drugs had a banner year in 2015, seeing more than 700 full and tentative approvals, the agency announced in April in its first-ever report on generics. Read More
FDA regulators are pushing back the clock on orphan drug reviews from 90 days to 120 days in an effort to keep pace with heavier-than-expected workloads. Read More
The UK’s drug pricing watchdog is backing coverage for Human Genome Sciences’ Benlysta as an add-on treatment for systemic lupus erythematosus. Read More
The UK’s drug pricing watchdog seems to have warmed to AbbVie’s Humira, recommending the drug be covered four months after one of its committees proposed rejecting it. Read More