The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Source: International Pharmaceutical…
The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone…
UK’s MHRA reclassified Pfizer’s Viagra (sildenafil), allowing it to be sold over the counter without a prescription, branded as Viagra Connect. Previous versions of the tablet will still be available…
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described…
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in…
U.K. regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination.…
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…
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on…
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Source: International Pharmaceutical Regulatory Monitor