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Bipartisan lawmakers in Congress introduced five bills last week meant to shore up the U.S. supply chain and address the rising costs of prescription drugs. Read More
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
Many biopharmaceutical sponsors are prepared to see the costs of outsourcing increase for their clinical trials in 2022 as the practice is expected to significantly increase this year, according to an industry survey by Baird. 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