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The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. Read More
The Therapeutic Goods Administration is considering raising the maximum limit for classifying rare diseases and specific subsets of patients to broaden the scope of medications that qualify for orphan drug status. Read More
The agency is concerned that the amount and frequency of doses given to patients were subject to investigator discretion and often inconsistent. Read More
The House Energy and Commerce Committee has released a new draft of its 21st Century Cures Act that would encourage greater use of observational studies, patient registries and real-world therapeutic use to support approvals of new drugs and improve postmarket surveillance. Read More
Republicans on the Senate HELP Committee are taking the FDA to task for failing to shore up policies on biosimilar naming and interchangeability before approving the first biosimilar drug nearly two months ago. Read More
Manufacturers of over-the-counter antiseptics used in healthcare settings will need to submit new safety data to the FDA if they want to keep their products on the market, the agency said Thursday, citing growing concerns about the systemic effects of long-term exposure to certain active ingredients. Read More
Two FDA advisory committees voted late Wednesday to recommend approval of Amgen’s talimogene laherparepvec immunotherapy for patients with metastatic melanoma, overriding FDA reviewers’ concerns that results from a pivotal clinical trial were skewed. Read More