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 Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
Clinical Research Solutions
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Clinical Research Solutions
On Thursday, April 20th, the FDA formally ordered both Texas and Arizona to refuse and either destroy or export all execution drugs within 90 days. Background Texas was the first state to begin...
Clinical Research Solutions
On Thursday, April 20th, the FDA issued a statement announcing a number of changes that are being made to the labeling requirements for two opioids – codeine and tramadol. The Agency’s statement...
Clinical Research Solutions
On Friday, April 14th, a draft bill was released, aimed at reauthorizing the user fee programs for branded and generic drugs, medical devices, and biosimilar products. Committees from the House of...
Clinical Research Solutions
On Friday, March 31st, the FDA informed consumers of “Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products.” These...
Clinical Research Solutions
On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis. What is Atopic Dermatitis? Atopic...
Clinical Research Solutions
On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism. In the notice published in the Federal Register, the FDA notes...
Clinical Research Solutions
In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016. In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic...
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
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
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...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
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...