Federal judge enters consent against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx for drug, device, and dietary supplement violations. A federal judge in Tennessee ordered a consent decree of permanent injunctions against two Tennessee-based companies, Basic Reset and Biogenyx. The permanent injunction prohibits the two companies and their owners from distributing
Notice of intent to inactivate outdated drug listing records. The FDA has announced its intention to begin inactivating drug listing records that are not properly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date; or are associated with a manufacturing establishment that is not
FDA announces the user fee rates for prescription drugs, generic drugs, biosimilars, and outsourcing facilities for FY 2020 As part of the FDA, CDER also known as the Center for Drug Evaluation and Research regulates new drugs including prescription and generic drugs, before they can be sold. The FDA is authorized to collect application fees
FDA announces the MDUFA fees for FY 2020. The FDA announced its fee rates and payments procedures for medical device user fees for the FY 2020. Fee rates for FY 2020 were adjusted for inflation. The fee rates go into effect from October 1, 2019 to September 30, 2020.The application fee should be paid for
What Medical Device Companies Need to Know The path to medical device commercialization in the U.S. is long and complex with many hurdles. The two most significant challenges are obtaining FDA approval and positive coverage decisions from payers. The most important players in these coverage decisions are Medicare and large commercial insurers, such as Aetna,
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
mdi Consultants, Inc