Biosimilar Regulatory solution center
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FDA Seeks Comment On Conducting Remote Regulatory Assessments
8/11/2022
The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.
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Data: The Near Future Of Regulatory Info Management In Europe
7/29/2022
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
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Apheresis Variability Control In Cell Therapy Manufacturing
7/25/2022
Explore our best practices for apheresis collection and obtention of enriched product for cell therapies.
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CAPA System Best Practices For GMP Compliance
7/25/2022
A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices.
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FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
7/5/2022
ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry.
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FDA Updates Guidance For Investigating OOS Test Results
6/24/2022
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
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FDA Publishes Guidance For Biopharma Container And Carton Label Design
6/13/2022
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
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FDA Finds Drug Shortages Are Mostly Caused By Quality Issues
6/6/2022
New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
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Regulatory Convergence With Aurion Biotech
5/18/2022
Advanced therapeutics are as complex as they are promising. Establishing a global regulatory strategy for these modalities requires a comprehensive, multifaceted approach.
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Make This Your New EU IDMP Implementation Strategy
5/9/2022
Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.