The Food and Drug Administration (“FDA”) regulates and categorizes human cell and tissue products (“HCT/Ps”) based on the public health risks they pose. HCT/Ps are biological products that are used to repair, replace or regenerate human... Read More
PRESS RELEASE – New Jersey/New York, March 28, 2023 – Jonathan Levitt, a renowned trial attorney in the healthcare and life sciences industries and the co-founding partner of Frier Levitt, has been invited to testify before the U.S. Senate... Read More
Pharmacies and pharmacists (“licensees”) throughout the country are often anxious after learning that a State Board of Pharmacy (“BOP”) is seeking disciplinary action against them. The fear of challenging a BOP’s allegations, the same... Read More
In Texas, licensees are informed of the Board of Pharmacy’s (“BOP”) allegations against them through a document called the Statement of Allegations. Some of the information usually contained in the Statement of Allegations includes: (1) a... Read More
State Boards of Pharmacy (“BOPs”) throughout the country are authorized to handle issues with the licensees they regulate, including pharmacies and pharmacists (“licensees”) through various means. For example, the various laws governing BOPs... Read More
State Boards of Pharmacy (“BOPs”) throughout the country are empowered through various laws, rules, and regulations governing administrative agencies, like BOPs, to handle issues with the licensees they regulate, including pharmacies and... Read More
State Boards of Pharmacy (“BOPs”) throughout the country rely on various types of proceedings, both formal and informal, to handle legal issues with licensees (pharmacies, pharmacists, etc.) conducting business in their state. Oftentimes, less... Read More
In a win for pharmacy in the decade long squirmish between FDA and compounding pharmacies, FDA has been ordered to conduct a review of its MOU. The MOU establishes an understanding between individual State Boards of Pharmacy and the FDA involving... Read More
Worldwide there are fewer than 500,000 people with hemophilia, a genetic disease that inhibits a patient’s blood clotting ability. Hemophilia is caused by genetic mutations in a patient and is hereditary, meaning that the condition is often passed... Read More
Question: What could be worse than a PBM audit? Answer: A PBM audit coupled with a State Board of Pharmacy investigation. As we have written on previously, Frier Levitt is witnessing an uptick in PBM-initiated complaints to State Boards of... Read More
