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Clinical Research Solutions
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017...
Clinical Research Solutions
On August 8, 2016, the FDA issued a final rule outlining its refuse to accept policy for premarket tobacco product submissions failing to meet the minimum threshold of acceptability for FDA review....
Clinical Research Solutions
On Friday, January 27th, the FDA published a press release warning consumers of elevated levels of belladonna in certain homeopathic teething products. According to the announcement, an FDA-conducted...
Clinical Research Solutions
On Wednesday, January 25th, the FDA issued Import Alert 89-17, which banned the import of Nipro’s piston syringes (with luer lock tip or catheter tip) into the US from the company’s Thailand...
Clinical Research Solutions
On Wednesday, January 25th, the FDA unveiled a critical data update to Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.” According to the...
Clinical Research Solutions
After various industry professionals and stakeholders expressed an interest in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft...
Clinical Research Solutions
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled “Pediatric Study Plans: Content of and Process for Submitting...
Clinical Research Solutions
On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer...
Clinical Research Solutions
The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA...
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...