Risk management plans are an increasingly common feature of new drug approvals, and Congress seems set on making them a standard part of the FDA review process. Industry seems willing to go along, accepting some more restricitions on new products in exchange for restoring confidence in drug safety. There is only one problem: FDA is not so sure this is a great idea.
By Michael McCaughan
Everyone seems to agree that risk management programs are a big part of the answer to resolving concerns about the safety of prescription drugs.
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The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.
Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.
At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.
