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Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More
In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products. Read More
The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More
The increased use of fast track regulatory pathways has led to the FDA having the shortest median approval time for new active drug substances in 2017 compared to five other international regulatory agencies, according to the UK-based Centre for Innovation in Regulatory Science (CIRS). Read More
CDER released a revised Manual of Policies and Procedures on expedited reviews of prior approval supplements for new drug and biologics license applications that involve chemistry, manufacturing and controls changes. Read More
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