Blogs

R&A blog content

  • Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

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  • Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

    Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

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  • How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

    How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

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  • When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    When Off-Label is Your Biggest Competition: Rituximab in Autoimmune Diseases

    About the Authors Mansi Shinde, Ph.D. is an Engagement Manager based in the...

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  • Hong Kong Exchange: Nurturing China’s Biotech Valley

    Hong Kong Exchange: Nurturing China’s Biotech Valley

    About the Authors Daniel Huang is an Analyst based in the Hong Kong...

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...

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  • An overview of the recent Executive Order on Critical Drugs Made in America

    An overview of the recent Executive Order on Critical Drugs Made in America

    On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...

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  • The Move Toward Global Standards: Navigating New EAEU Guidelines

    The Move Toward Global Standards: Navigating New EAEU Guidelines

    As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

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  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

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  • NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

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  • Has EMA started a domino effect for more regulation of API manufacturing?

    Has EMA started a domino effect for more regulation of API manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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