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The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying such nonclinical studies should consider general toxicology, pharmacology and reproductive toxicology. Read More
The FDA finalized guidance on its special protocol assessment (SPA) program that offers sponsors an advanced declaration from the agency that their trial designs, clinical endpoints, and statistical analyses are acceptable. Read More
In a landmark decision for U.S. patent law, and to the disappointment of some drug makers, the U.S. Supreme Court upheld the legality of inter partes reviews, preserving a method that makes it easier to challenge and invalidate dubious patents. Read More
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Read More
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s senior international officials said. Read More
In a move applauded by domestic drug groups, the U.S. Trade Representative added Canada to its priority watch list of countries with lax intellectual property protections or market access barriers for drugs. Read More
The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility for the program that provides early scientific and regulatory support for medicines based on promising preliminary clinical evidence. Read More
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization. Read More
In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines. Read More
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Read More