Blogs

R&A blog content

  • How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance

    How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance

    The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...

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  • It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too

    It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too

    In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...

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  • NDA to BLA Transition Products, FDA List Grew Recently

    NDA to BLA Transition Products, FDA List Grew Recently

    FDA has reviewed and approved the majority of therapeutic biological products (i.e. Biotechnology Products) under the Public Health Service (PHS) Act.  Most are submitted as BLAs and most...

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  • Between Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities

    Between Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities

    In January 2020 the Food and Drug Administration (FDA or “agency”) published the revised draft guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing...

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  • Beware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!

    Beware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!

    Donor Eligibility (DE) determination is a central aspect of how FDA and other regulatory authorities ensure that a product from a single allogeneic donor has acceptable very low risk of...

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  • FDA Inspections and Cleaning

    FDA Inspections and Cleaning

    Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection.  Often cleaning validation studies are extensively...

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  • Can FDA Really Do That? Understanding FDA’s Jurisdiction

    Can FDA Really Do That? Understanding FDA’s Jurisdiction

    On August 29, 2019 the US FDA sent a Warning Letter to Shanghai Institute of Pharmaceutical Industry (SIPI) (see the Warning Letter).  The FDA charged the firm with refusing a pre-announced...

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  • Rare Disease and Orphan Drug Designations - What You Need to Know

    Rare Disease and Orphan Drug Designations - What You Need to Know

    Collectively, rare diseases affect over 30 million Americans.  The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...

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  • Critical Differences Between a Form FDA 483 and Warning Letters

    Critical Differences Between a Form FDA 483 and Warning Letters

    There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...

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  • Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...

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  • Reimagining The Global Value Dossier - Part 6

    Reimagining The Global Value Dossier - Part 6

    A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...

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  • Will FDA Withdraw an Approved Application Over Product Quality Problems?

    Will FDA Withdraw an Approved Application Over Product Quality Problems?

    There have been some recent headlines where the acting FDA Commissioner and other senior agency officials have stated that the FDA will consider the use of its full authorities to take...

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  • Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t

    Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t

    In a recent blog post, I wrote about how manufacturers can overcome data integrity problems that potentially imperil an application’s approval and commercializing a product. Sometimes...

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  • New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

    New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

    On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...

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  • Commercial and Regulatory Strategy Considerations for Biotech

    Commercial and Regulatory Strategy Considerations for Biotech

    Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...

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  • How to align your market access activities with your product value strategy

    How to align your market access activities with your product value strategy

    The value strategy (also termed value story) for your product should act as the cornerstone for all market access activities.  The value strategy drives your market access planning, which...

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  • A Long and Winding Road for Transdermal Products – FDA Has It Covered

    A Long and Winding Road for Transdermal Products – FDA Has It Covered

    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...

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  • Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...

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  • Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...

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  • Biosimilars in China: Riding an upward trend

    Biosimilars in China: Riding an upward trend

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

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