ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to...
Clinical Research Solutions
On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for...
Clinical Research Solutions
Evaluating the Abuse Deterrence of Generic Opioid Drug Products As we recently reported, the prevalence of opioid abuse and overdose have reached epidemic levels in the U.S. over the past decade. In...
Clinical Research Solutions
On March 17th, a bipartisan group of Senators on the Health, Education, Labor, and Pensions (HELP) committee introduced a bill entitled The FDA and NIH Workforce Authorities Modernization Act. The...
Clinical Research Solutions
On March 17, 2016, the Improving Medical Device Innovation Act was introduced in the Senate’s Health, Education, Labor, & Pensions (HELP) committee. The bill, championed by Senators Amy Klobuchar (D...
Clinical Research Solutions
On Tuesday, March 22 the FDA announced class-wide safety labeling changes for all immediate-release opioid painkillers. FDA stated that these changes are being made as part of the Agency's...
Clinical Research Solutions
On Tuesday March, 22nd FDA announced a public conference, entitled “Aligning Manufacturing Goals with Patient Needs through Successful Innovation and Compliance,” to be held in co-sponsorship with...
Clinical Research Solutions
In October 2015 the FDA established its first ever Patient Engagement Advisory Committee (PEAC). This was done as part of the Agency’s 'patient-centric' approach, under which FDA is attempting to...
Clinical Research Solutions
FDA’s Proposed Study on Consumer Understanding of Quantitative Information in DTC Drug Ads In October 2015, the FDA announced plans to conduct a study which would determine how much quantitative...
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...