In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
- Your 6 Priority Areas For A Successful 2024
- Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
- Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
- A Brief Introduction To Environmental Monitoring For Startups
- Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
- Your Local Affiliates Want More From Your Global Regulatory Information Management
- Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges
PHARMA ONLINE WHITE PAPERS
Critical Considerations For Buffer Preparation
Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.
Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
Aseptic Sampling Devices In A Bioburden Reduction Strategy8/31/2022
This paper delves deeper into aseptic sampling devices to explain how they offer exceptional performance in the effort to control contamination.
Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
Dwell Volume And Extra-Column Volume: What Are They And How Do They Impact Method Transfer?9/22/2022
Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
Rational Design And Development Of Long-Acting Injectable Dosage Forms1/26/2022
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
On the surface, the future laboratory looks like an end to paper notebooks, adding solar panels on the roof, and lots of automation. But those are just the trimmings for a greater transformation as laboratories modernize. Check out the latest e-book from Pharmaceutical Online.More Content Collections