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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...
Regulatory Sciences
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 co-chaired by the...
For the first time, the FDA has issued a draft guidance for industry on “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”.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...
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...
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,...
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...
Here is the scenario: you are the leader of a group and you have been given the responsibility of driving the completion of a new initiative, an early or late-stage drug or devices program, or a...
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
News On 7 June 2022, EMA's Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised...
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...
Clinical Research Solutions
Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization....
The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. This is the harmonized guideline which has been ratified by participating...
Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...
Regulatory Sciences
FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products. This update was...
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...
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...