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Clinical Research Solutions
On December 31, 2015, FDA released a draft guidance entitled “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’),” which stated its plans to take a more aggressive...
Clinical Research Solutions
In September 2015, President Obama nominated Robert Califf, MD, a world renowned cardiologist and clinical trial expert, to serve as the next FDA Commissioner. Following his nomination, Dr. Califf...
Clinical Research Solutions
On Friday, January 22, FDA’s Center for Drug Evaluation and Research (CDER) published its 2016 guidance agenda. The guidance agenda is published on an annual basis and announces the draft guidances...
Clinical Research Solutions
The Food and Drug Administration Safety and Innovation Act (FDASIA), was signed into law on July 9, 2012. This law significantly expanded the FDA’s authority and strengthened its ability to safeguard...
Clinical Research Solutions
Earlier this month, FDA’s Center for Biologics Evaluation and Research (CBER) published its annual guidance agenda. CBER’s list is published in addition to the FDA’s agency-wide Annual Guidance...
Clinical Research Solutions
On December 31, 2015, the FDA issued a Warning Letter to Zhejiang Hisun Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer, citing the company for serious data...
Clinical Research Solutions
Over the past few years, we have seen a drastic upsurge in the amount of FDA activity involving Indian Active Pharmaceutical Ingredient (API) manufacturers. The Pharmaceutical Industry & FDA’s...
Clinical Research Solutions
On January 15, 2016, FDA published a draft guidance providing medical device manufacturers with a number of recommendations to protect patients from cybersecurity vulnerabilities in their devices....
Clinical Research Solutions
Earlier we provided you with details on FDA's recent draft guidance on cybersecurity in medical devices. Were you left wanting more? Well if you were wishing for additional information on the...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...