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The Latest in Regulatory and Reimbursement
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The Acting Director of the FDA’s Center for Drug Evaluation and Research (CDER) is retiring this month. The FDA unveiled a new priority voucher program, conducted a CEO listening tour across the country, and launched an agency-wide artificial intelligence tool. HHS facilitated a pledge with insurance companies to reform prior authorization processes and HRSA-funded health centers will be providing insulin and injectable epinephrine at a lower cost.
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FDA CDER Acting Director Retiring This Month
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Dr. Jacqueline Corrigan-Curay, Acting Director of the Center for Drug Evaluation and Research (CDER), has announced that she is leaving her position in July after almost nine years with the agency. Former clinical team leader, Mike Davis, will return to the FDA as CDER’s Deputy Director. |
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New Commissioner’s National Priority Vouchers
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FDA Hosts CEO Listening Tour Across the Country
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Commissioner Makary and CBER Director Prasad conducted a listening tour, which included stops in San Francisco and San Diego, to hear directly from biotech and pharma leaders about how the FDA can modernize its regulatory framework. |
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FDA Launches Agency-Wide Artificial Intelligence Tool
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Launched last month, Elsa is a language model-powered AI tool designed to assist FDA employees with reading, writing, and summarizing documents. It is not intended to be used on research and data submitted by regulated industry. |
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Insurance Industry Pledges to Reform Prior Authorizations
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HHS Secretary Kennedy and CMS Administrator Oz met with insurance industry leaders as part of a roundtable event to discuss a pledge with six key reforms to improve prior authorization processes for Medicare Advantage, Medicaid Managed Care, Health Insurance Marketplace, and more. |
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Lower Cost Insulin and Injectable Epinephrine
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As directed by the President’s drug pricing Executive Order, the Health Resources and Services Administration (HRSA) issued updated award terms requiring HRSA-funded health centers to provide insulin and injectable epinephrine to low-income patients at or below the price paid through the 340B Program. |
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance document. Click here to submit comments via email. |
► Replacing Color Additives in Approved or Marketed Drug Products
- Provides recommendations for replacing color additives in approved or marketed drug products.
- Additionally, this draft guidance recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit information to support color additive replacements in changes being effected in 30 days (CBE-30) supplements.
- This draft guidance recommends a CBE-30 for such a change.
This guidance may be of interest to drug sponsors and manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Gilead Sciences on the FDA approval of Yeztugo, an injectable pre-exposure prophylaxis that is administered once every six months to reduce the risk of sexually acquired HIV.
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Biocom California
For over 30 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. We connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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