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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
The Centers for Medicare and Medicaid Services (CMS) issued proposed regulations in February targeting manufacturer arrangements with pharmacy benefit managers (PBMs).
A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law.
The Drug Enforcement Administration (DEA) recently announced an enhancement to the Automation of Reports and Consolidated Orders System (ARCOS) to allow DEA-registered drug manufacturers and distributors to access anonymized information concerning their customers’ orders of certain controlled substances.
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update.
The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.
The New York State Drug Take Back Act (Act), which was signed into law on July 10, 2018, went into effect on January 6, 2019.
In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019.
Human cell and gene therapy research has advanced dramatically in recent years and opened the door to potential treatments for diseases once considered incurable.
After several delays, the revised US Federal Policy for the Protection of Human Subjects (also known as the Common Rule) went into effect on January 21.
FDA recently signaled that it plans to be more involved in facilitating expanded access to investigational new drugs. This follows the agency’s announcement of its efforts to improve and clarify the expanded access program (EAP), as well as state and federal legislation intended to simplify the process to use investigational drugs for treatment purposes.