CDRH appeals processes and provides guidance pertaining to FDA significant decisions. The Center for Devices and Radiological Health (CDRH) issued an updated guidance document describing the processes available for individuals outside of the FDA to request a review of the decisions made by the CDRH on which they disagree with. Such processes that are recommended
FDA releases a proposed rule on biologics license applications and master files The FDA issued a proposed rule to amend its regulations relating to the use of master files for biological products. As per the requirements of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), marketing applications for biological products that previously could
FDA to provide new data regarding eligibility for 180-day exclusivity. The FDA enhanced their Paragraph IV Patent Certifications list in efforts to improve approval times for generic drug applications, this past week. The Paragraph IV Patent Certifications list contains relevant information to eligibility for 180-day exclusivity for generic drug products for those who have submitted a substantially complete abbreviated new drug application (ANDA)
Given the complexities of reimbursement, what can a manufacturer do to influence the process and achieve the best possible result? First and foremost, it is never too soon to begin thinking about issues related to coverage and reimbursement. Many companies develop unique medical devices with the expectation that issues such as coding, coverage and payment
Implementation of CDRH’s New Office of Product Evaluation and Quality. This week the FDA announced the official implementation of the Office of Product Evaluation and Quality (OPEQ) within the FDA’s Center for Devices and Radiological Health (CDRH). OPEQ has been established as a key step for the CDRH during the current period of reorganization. The
Unique Device Identification Program: The FDA Finalizes Guidance for Convenience Kits! FDA finalized the guidance, “Unique Device Identification: Convenience Kits,” which describes the FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only. This guidance does not apply to in vitro diagnostic (IVD) devices that are subject
In the US, there are publicly funded payers such as Medicaid and Medicare, and privately funded payers such as managed care companies. In general, the extent and range of benefits provided are governed by law in public payer systems and by contracts between the private payers and the purchasers of health care (usually employers). Medicare
CBD Update Last week, the outgoing FDA commissioner, Scott Gottlieb, announced that his agency will be using “enforcement discretion” to target products containing cannabidiol (CBD) that are making ‘over-the-line’ claims on their products. Gottlieb defines ‘over-the-line’ claims as claiming to cure cancer or prevent Alzheimers or other diseases. These claims could mislead a patient to
FDA & CBD: Looking forward The FDA has announced plans to hold a public meeting next month (April 2019) for the creation of “an appropriately efficient and predictable regulatory framework for regulating cannabidiol (CBD) products,” including food and supplements, Commissioner Scott Gottlieb said during testimony before the House Appropriations Committee. This is hopeful news for
When you are asked: “Why should I use your medical device when the device I’m using now results in patient outcomes which seem to be adequate”, your answer should be a convincing value story (aka value proposition). A VALUE STORY is a clear and concise statement which demonstrates the clinical and economic benefits of using your
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