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Clinical Research Solutions
On Friday, July 29th, FDA announced its 2017 Medical Device User Fee rates and payment procedures, which will take effect on October 1, 2016 and remain in place until September 30, 2017. These fees...
Clinical Research Solutions
The Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). These user...
Clinical Research Solutions
The Prescription Drug User Fee Amendments of 2012 (PDUFA V) allows FDA to collect user fees for the review of applications concerning human drug and biological products, the establishments where...
Clinical Research Solutions
On September 24, 2013, the FDA published the UDI Rule, which established a standardized identification system for medical devices used in the United States. Under this rule, the label and packages of...
Clinical Research Solutions
On Friday, July 22nd, the European Medicines Agency (EMA) recommended the suspension of hundreds of drugs that had undergone bioequivalence testing at Semler Research Centre Private Ltd., a clinical...
Clinical Research Solutions
On Friday, July 22nd , the FDA published three public notifications warning consumers of hidden drug ingredients that are present in various Xcelerated Weight Loss products. Two of the company’s...
Clinical Research Solutions
In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...
Clinical Research Solutions
On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors...
Clinical Research Solutions
On July 28, 2015, the FDA published a draft guidance, entitled “Request for Quality Metrics.” The draft guidance “outlines FDA’s authority to require owners and operators of such establishments to...
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...