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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


New FDA Guidance for Medical Device Reporting for Manufacturers

On November 8, 2016, the FDA issued the long awaited final guidance, “Medical Device Reporting for Manufacturers.”  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm359566.pdf  The final guidance addresses medical device reporting and recordkeeping requirements for device-related adverse events and certain types of device malfunctions.  The guidance supersedes the…

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…

White Paper


What is an ICER and Why Should You Care?

The healthcare environment is changing rapidly and at all levels.  Value used to be defined as the number of procedures, products, or patients.  That is no longer the case and the challenge is therefore to define value, particularly where there are existing…

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