Quality & compliance

  • FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

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  • Navigating new steps in how FDA is managing COVID-19 Products

    Navigating new steps in how FDA is managing COVID-19 Products

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  • Keeping ahead of the regulatory curve – Stay open for business

    Keeping ahead of the regulatory curve – Stay open for business

    On April 21, 2020, a proposed piece of legislation was introduced in the U.S. House of Representatives. The proposed bill is titled “COVID-19 Every Worker Protection Act of 2020” and is identified...

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  • Biosimilars in the time of COVID-19 and beyond

    Biosimilars in the time of COVID-19 and beyond

    Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

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  • Considerations for protecting your business and employees from COVID-19

    Considerations for protecting your business and employees from COVID-19

    This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.

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  • Understanding the COVID-19 regulatory procedures the FDA is using

    Understanding the COVID-19 regulatory procedures the FDA is using

    A diagram that shows various procedural steps when interacting with the FDA through CTAP.

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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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