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To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More
Sponsors of new drugs and biologics intended to treat chronic pain should plan on submitting more safety data than they would to support candidates for acute pain, the FDA says. Read More
As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More
Merck & Amgen will collaborate on a Phase Ib/II trial evaluating Merck’s MK-3475 in combination with Amgen’s talimogene laherparepvec anti-cancer immunotherapies. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FTC Tuesday said regulations and legislation governing the naming and dispensation of biosimilars should match those already in place for generic drugs to avoid chilling competition among drugmakers. Read More
Following the FDA’s lead, the Scottish Medicines Consortium (SMC) said Monday it plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
House lawmakers have proposed legislation that would restrict the bulk distribution and use of dextromethorphan (DXM) in finished drugs in a bid to help curb adolescent abuse of OTC cold and cough medicines. Read More