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The FDA and Centers or Medicare and Medicaid Services (CMS) took the rare step Friday of issuing a joint statement to clarify their regulatory authorities one day after the CMS made a controversial decision on who will have Medicare-paid access to the Alzheimer’s drug Aduhelm (aducanumab). Read More
The FDA is proposing a rating system to assess drugmakers’ quality management maturity (QMM) as a way to protect against drug shortages and bolster the U.S. supply chain. Read More
The FDA has released final guidance marking the agency’s adoption of the International Council for Harmonization (ICH)’s E8(R1) guidelines on clinical trials, which call for a “quality by design” approach. Read More
Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Read More
The FDA is reaching out to states that have filed applications with the agency seeking approval to directly import prescription medicines from Canada. Read More
Alzheimer’s disease drug Aduhelm and other investigational anti-amyloid antibodies similar to Aduhelm will only be covered by Medicare and Medicaid if they’re used in the setting of a federally approved study, the Centers for Medicare and Medicaid Services (CMS) announced yesterday. Read More
Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year in 2022. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a Stronger FDA. Read More