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News & Events

Upcoming Events in May & June 2017

The BBA team will be attending and presented at several events this spring. EuroPCR – May 16-19, Paris France Arena Outsourcing in Clinical Trials – May 23-24, King of Prussia, PA BBA Podium Presentation: New Study New Challenges: The Power of a…

News & Events

Dr. Joe Massaro to Present at Interim Analysis Symposium

Marlborough, MA – Joe Massaro, PhD, Senior Consultant, BioStatistics at BBA, will present on the topic of Data Monitoring Committees (DMC or DSMB) during his talk titled, “Design and Operate a High-Performing Data Monitoring Committee to Better Assess Trial Outcomes.”  In addition…

White Paper

Boston Biomedical Associates Announces FDA eCopy Services

The FDA’s eCopy requirements for medical device regulatory submission has presented a plethora of new challenges and pitfalls for manufacturers who are trying to navigate the FDA’s regulatory process. If a company is not experienced with the process and requirements, a submission…

Fact Sheet

CDRH Modular PMA Alert – Process Changes

The FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016. The memo addresses how incoming Modular PMA submissions will be…

Fact Sheet

Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership. A session at the 2015 RAPS’ Regulatory Convergence in Baltimore discussed the differences between regulatory information and regulatory intelligence. Which are you paying for when you hire…

White Paper

The What, When, and How of Clinical Registries

Why a registry? Patient registries are an excellent data collection tool to use in today’s health care environment, particularly when there is a need to characterize or expand a patient population for a treatment, to develop new information which can be used…

Fact Sheet

Updated FDA Requirements for AED Systems

Effective on February 3, 2015 the Food and Drug Administration issued a final order requiring premarket approval applications (PMA) to be filed for automated external defibrillator (AED) systems and accessories (such as pad electrodes, batteries, and adapters). This order was prompted by…

News & Events

The Capital Network “Life Science Fast Track”

November 18, 2014 Boston, MA Mack Rubley, Vice President Consulting Services at BBA spoke at the Life Science Venture Fast Track event on November 18, 2014 in Boston on the topic of Regulatory Strategy. The meeting was attended by entrepreneurs and investors…

White Paper

Pathways for IDE Approval: Which Best Fits Your Needs?

There are several options for sponsors who are seeking IDE approval or FDA feedback regarding an IDE. Each option offers different benefits, depending on what type of trial the sponsor is seeking to initiate and how much time the sponsor is looking…

White Paper

De-Mystifiying the De Novo Process

The De Novo process was first introduced in 1997 with the implementation of the FDA’s Modernization Act (FDAMA). [1] It was meant as a means to reclassify novel devices of low to moderate risk profiles that were automatically deemed Class III because…

BBA News and Blog

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