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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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  • Press announcement: Parexel unveils combined Regulatory & Access consulting organization

    Press announcement: Parexel unveils combined Regulatory & Access consulting organization

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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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  • 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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  • 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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  • 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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  • 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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  • Rescuing Product Approvals from Data Integrity Issues

    Rescuing Product Approvals from Data Integrity Issues

    The pharmaceutical industry is inundated with a plethora of communications about data integrity.  Most of those are focused on the downside – operational snags, negative inspection findings,...

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  • Reimagining the Global Value Dossier - Part 4

    Reimagining the Global Value Dossier - Part 4

    Health Technology Assessment (HTA) agencies are increasingly demanding the inclusion of patient-relevant data in submission dossiers. It is evident that there is an effort to ensure...

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  • Commercializing Gene and Cellular Therapy

    Commercializing Gene and Cellular Therapy

    Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities.  Designing a facility or finding a contract manufacturer to meet the...

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  • Capturing the patient voice in market access communications

    Capturing the patient voice in market access communications

    Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...

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  • Landscape assessment and key HTA considerations in Alzheimer’s disease

    Landscape assessment and key HTA considerations in Alzheimer’s disease

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  • Reimbursement of ultra-orphan medicines

    Reimbursement of ultra-orphan medicines

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