Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.   The committee will also meet on 26 October to discuss Pfizer's anticipated request...

The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...

Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...

US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications. FDA  launched the pre-cert pilot  in July as part of the agency’s  Digital Health Innovation Action Plan. The pilot participants, representing a range of companies and technology in the ...

Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector. Background On 27 June, a cyberattack involving ransomware known as "Petya" or "NotPetya" infected government and business computer systems in Ukraine before spreading to other corporate networks around the world. M...

This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package. On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter , overhaul FDA's inspection program for device establishments , ...

The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile. The eight-day inspection last February uncovered four observations detailing : Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up Procedures designed to prevent microbiological...

Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector. The letter comes amid a frenzy of Congressional outrage over the more than 400% spike in the price of Mylan’s life-saving EpiPen for those suffering from severe allergies that hasn’...