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As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
Clinical Research Solutions
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and...
Regulatory Sciences
Developing in vitro diagnostic tests, laboratory-developed tests, medical devices, or therapeutics is complex and requires careful consideration of various factors. One critical aspect that often...
By now, most involved in the clinical trials disclosures field are aware of the upcoming reinstatement of the European Medicine Agency's (EMA) landmark transparency regulation: Policy 0070. Policy...
Securing funding is a crucial milestone for biotech startups aiming to advance their research and bring innovative products to market. Once the initial round of funding is secured, the next challenge...
FDA Provides Acceptable Intake Limits for Nitrosamines Drug-Substance Related Impurities (NDSRIs). Can You Comply? The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled;...
Biotech startups face a number of challenges as they progress through the various stages of drug development. While early-stage biotechs focus on developing and testing their products, late-stage...
COVID-19 has presented humankind with the challenges expected from a pandemic with over 700 million cases and almost 7 million deaths1. While the mRNA technology was not widely known in the news, it...
On April 26th, 2023, a Commission formed by the European Health Union proposed a groundbreaking revision of the EU’s Pharmaceutical legislation, marking the most significant reform in over two...
Clinical Research Solutions
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....
Clinical Research Solutions
In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...
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...
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...
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...
A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
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...