Featured Pharma Online Editorial
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Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations
4/21/2023
Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.
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Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
4/20/2023
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
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Congressional Changes For Orphan Drug Approvals?
4/18/2023
Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.
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Strength Biowaivers For Immediate Release Oral Solid Drug Products: European & American Perspectives
4/13/2023
A strength biowaiver is usually claimed for an additional strength when bioequivalence has been established for one strength and the biopharmaceutics classification system biowaiver is not applicable. Six factors need to be considered with additional strength biowaivers, and this article shares the regulatory requirements in the U.S. and Europe.
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New DSCSA Compliance Blueprint Includes FDA & Industry Input
4/12/2023
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
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Final Guidance Locks In FDA’s Definitions For Suspect And Illegitimate Drug Product
4/7/2023
With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
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Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi
3/14/2023
It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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Draft FDA Labeling Guidance Proposes More Clarity For Providers
3/7/2023
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.