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Clinical Research Solutions
What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...
Clinical Research Solutions
This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
Clinical Research Solutions
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
Clinical Research Solutions
In 2020, the European Commission (EC) requested EMA and European Food Safety Authority (EFSA) for advice for the development of a harmonised approach on exposure assessment methodologies for residues...
Clinical Research Solutions
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. Oligonucleotides are short single...
Clinical Research Solutions
Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This...
Clinical Research Solutions
Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare diseases and other conditions with unmet clinical needs. As of 2022, sixteen ATMPs have been approved by...
Clinical Research Solutions
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
Clinical Research Solutions
Guilty as charged! I used to think a project manager’s (PM) sole job was to remind everyone about deadlines and set up status meetings. I learned firsthand while working at a medical device start-up,...
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...