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The FDA issued final guidance on electronic submissions of drug master files, giving sponsors of Type III DMFs for packaging materials an extra year before submission requirements kick in. Read More
The FDA announced a new pilot program in which drug sponsors can meet with agency officials to discuss strategies for model-informed drug development (MIDD) to make their clinical trials more efficient and increase the chances of regulatory approval. Read More
Citing concerns among stakeholders including the FDA, the U.S. Pharmacopeia decided not to move forward with proposed revisions to its nomenclature for biologics. Read More
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or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
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
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
Allergan’s contested patents for the dry-eye drug Restasis took another potential hit last week as four major retailers filed an antitrust lawsuit against the drugmaker. Read More