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Clinical Research Solutions
FDA Publishes Responses to Good Clinical Practice Inquiries: FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations....
Clinical Research Solutions
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
Clinical Research Solutions
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
Clinical Research Solutions
Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022 FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care...
Clinical Research Solutions
Today, the U.S. Food and Drug Administration (FDA) issued a final rule: Establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of...
Clinical Research Solutions
GUIDANCE DOCUMENT - Guidance for Industry and FDA Staff AUGUST 2022 In 2003, FDA issued an updated guidance on the "Replacement Reagent and Instrument Family Policy" for in vitro diagnostic (IVD)...
Clinical Research Solutions
Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...
Clinical Research Solutions
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
Clinical Research Solutions
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
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...