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The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Read More
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain — one recommending data and documentation practices and another defining terms such as “suspect products” and “illegitimate products.” Read More
The FDA issued final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More
The FDA updated its guidance to institutional review boards and clinical investigators, detailing its views on reimbursements for lodging and travel for clinical trial participants. Read More
Drug products seeking an FDA designation as a medical countermeasure — defined as products used to diagnose, prevent or treat conditions associated with chemical, biological, radiological and nuclear threats — must not be previously approved for another indication, the agency said, in a new draft guidance. Read More
The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More
Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Read More
An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to adopt suffixes may offer little benefit for pharmacovigilance. Read More