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FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
The FDA cited a Chinese drug and API facility for a slew of violations of agency standards, based on an inspection of the company’s plant in Tianmen. Read More
Shortly after taking office in January, President Trump issued an executive order directing agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs exceeding benefits — and now the FDA is asking the public for suggestions. Read More