Pharma – Enzyme

Medical Devices PharmaFebruary 14, 2025

Tariff Wars, Generic Drug Manufacturing Strain Already Stressed Global Medical Product Supply Chains – Can Companies Adapt?

By Shawn M. Schmitt Communications Specialist, Enzyme The tariff wars underway between the US and an array of other countries is straining already-stressed supply chains for pharmaceuticals, medical devices, and other medical products, says an expert on global supply chain management. But there are things manufacturers can do to alleviate supply chain pain points caused...

Clinical Trials In Vitro Diagnostics Medical Devices Pharma RegulationJanuary 23, 2025

Q&A: Discussing the Power of Real-World Data With Flatiron Health’s Craig Serra

By Shawn M. Schmitt Communications Specialist, Enzyme If there’s anyone who understands the power of companies using real-world evidence (RWE) and real-world data (RWD) to support clinical development, it’s Craig Serra. Three years ago, Serra’s daughter was a mere 3 years of age when she was diagnosed with cancer. Serra was working in Global Development...

Clinical Trials In Vitro Diagnostics Medical Devices Pharma RegulationDecember 4, 2024

Ex-FDAer Says Real-World Data Just as Good as Clinical Data: ‘I Will Take This to the Grave’

By Shawn M. Schmitt Communications Specialist, Enzyme Call it “proving by doing”: A former Food and Drug Administration (FDA) official who led the effort to draft the US agency’s very first guidance document on real-world data says it’s imperative that pharmaceutical and medical device manufacturers shake off concerns about using RWD to support new product...

Clinical Trials In Vitro Diagnostics Medical Devices Pharma RegulationNovember 15, 2024

Embrace Real-World Evidence To Avoid Costly Prospective Randomized Trials That Can ‘Strangle Innovation,’ RWE Expert Says

By Shawn M. Schmitt Communications Specialist, Enzyme The widespread collection and use of real-world data (RWD) by pharmaceutical and MedTech manufacturers to support new product submissions is teetering on a tipping point in these industries, yet one expert and longtime RWD proponent says many companies are still gun-shy about presenting such data to a regulator’s...

PharmaOctober 12, 2023

FDA Guidance Provides Road Map for Use of Real-World Data and Evidence

The new FDA guidance on the use of real-world data (RWD) and real-world evidence (RWE) is a long-anticipated playbook for how a drug manufacturer can employ a non-interventional study for regulatory decision-making. The process is not as simple as extracting observational data from a registry, although the benefits are potentially immense given that the sponsor can avoid the need for an expensive and cumbersome randomized controlled clinical trial (RCT).

Artificial Intelligence Digital Health PharmaJune 6, 2023

FDA Releases Discussion Paper for AI in Drug Development

This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.

Artificial Intelligence Digital Health PharmaApril 5, 2023

FDA Takes Next Step Toward Digital Health in Drug Development

The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.

Artificial Intelligence Manufacturing PharmaMarch 21, 2023

FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing

The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.

Biotech PharmaFebruary 2, 2023

FDA Guidance Documents are Vital in De-Risking REMS

The FDA’s risk evaluation and mitigation strategy (REMS) requirements are among the most demanding of a pharmaceutical or biotech manufacturer’s postmarket requirements, and it is important to plan adequately for these programs, given the cost of a failed first attempt.

PharmaSeptember 22, 2022

ICH Expands on Analytical Methods Validation in Draft – Q2 Update

The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.

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