Blogs

R&A blog content

  • Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

    Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

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  • Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...

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  • What Influences the Compliance Culture at FDA?

    What Influences the Compliance Culture at FDA?

    The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization.  It has hundreds of personnel who are...

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  • Bioprocessing and Biologics risk from Coronavirus

    Bioprocessing and Biologics risk from Coronavirus

    Coronavirus COVID-19 has been all over the news recently.  This virus is part of a larger family called Coronaviridae, which includes viruses that can infect only animals, cause mild colds...

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  • CAR-T: How far have we come and where are we going?

    CAR-T: How far have we come and where are we going?

    In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....

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  • FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here).  Over time it has developed into the commonly recognized idea...

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  • Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...

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  • As PIC/S expansion continues, what does this mean for manufacturers seeking to join?

    As PIC/S expansion continues, what does this mean for manufacturers seeking to join?

    Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...

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  • 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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