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The trade association of the British drug industry dropped its legal challenge to new guidelines from national regulators that subject higher-priced drugs to an extra review under England’s single-payer National Health Service. Read More
The FDA replaced its 2001 guidance on organizing electronic common technical documents for submission, updating its recommendations to industry with the ICH’s M4 guideline. Read More
Finger-pointing abounded during a Senate hearing on prescription drug prices, where branded and generic industry representatives testified alongside pharmacy, wholesale distributor and benefit manager groups. Read More
Health Canada proposed fee hikes for reviewing new drug applications, oversight of manufacturing facilities, postmarket monitoring of sales and other regulatory activities. Read More
The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said. Read More
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for a single generic medicine and expansions of indications for six other drugs, during a light meeting this past month. Read More
The European Medicines Agency’s pharmacovigilance committee recommended additional restrictions on Biogen’s Zinbryta (daclizumab), after reviewing its effects on the liver. Read More
The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the plants has reached 70 percent of its pre-storm capacity, FDA Commissioner Scott Gottlieb told a congressional committee. Read More