The U.S. FDA released a draft guidance for computer software assurance, a document that spells out the agency’s expectations for computer systems used to log a manufacturing site’s compliance and manufacturing activities.
From the beginning of the monkeypox outbreak in the U.S. in May, the federal government has bungled the response, according to both Democratic and Republican members of the Senate Health, Education, Labor and Pensions (HELP) Committee.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Tasso.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Atyr, Biontech, Clovis, Cstone, H. Lundbeck, Hansa, I-Mab, Innocare, Merck, Novavax, Otsuka, Pfizer, TC.
The U.S. FDA has granted breakthrough device designation to Potrero Medical Inc. for its AKI Predict machine learning algorithm for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in intensive care patients recovering from cardiac surgery.
The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development.
Pricing new drugs for the U.S. market, especially those treating rare diseases, is getting a lot more complex now that the Medicare inflation rebate is in play. The rebate provision in the newly enacted Inflation Reduction Act incentivizes companies to set higher launch prices for drugs that will be used by Medicare beneficiaries since their future price increases will be limited to the rate of inflation. Although some of the other drug pricing measures included in the new law won’t kick in for a few years, the Medicare inflation rebate is to become effective next year.
More than four years after Right to Try legislation was enacted in the U.S., the FDA is issuing a final rule, Annual Summary Reporting Requirements Under the Right to Try Act, specifying the deadline and content for the annual reports the law requires participating drug sponsors or manufacturers to submit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ark Surgical, Ventris.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Biolinerx, BMS, Chiesi, Mersana, Vaxxinity.
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