Blogs

R&A blog content

  • 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...

    Learn More
  • What’s Around the Corner for FDA Inspections?

    What’s Around the Corner for FDA Inspections?

    There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...

    Learn More
  • Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

    Learn More
  • 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...

    Learn More
  • Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...

    Learn More
  • ×

    Speak to one of our experts today

    First Name
    Last Name
    Company Name
    Title
    Country
    Tell us how we can help
    We'll be in touch shortly!
    Error - something went wrong!
  • Putting the Pandemic in Plain Language

    Putting the Pandemic in Plain Language

    The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...

    Learn More
  • SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...

    Learn More
  • 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...

    Learn More
  • 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...

    Learn More
  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

    Learn More
  • Managing Continuity in Clinical Trials in the COVID-19 environment:  The Decentralized Option and Regulatory Flexibility

    Managing Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility

    Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

    Learn More
  • Vendor Audits and cGMPs

    Vendor Audits and cGMPs

    Industries are taking ongoing actions in their response efforts to COVID-19 and this includes being prepared for Regulatory Authority CGMP requirements which include Vendor Audits. FDA through...

    Learn More
  • Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...

    Learn More
  • COVID-19 Impact on Rare Disease Patients and Manufacturers

    COVID-19 Impact on Rare Disease Patients and Manufacturers

    About the Authors Yi Liu, PhD is a Senior Analyst in the Health...

    Learn More
  • 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.

    Learn More
  • Expediting Biotech Product Development During the COVID-19 Pandemic using Modular Validation Approaches

    Expediting Biotech Product Development During the COVID-19 Pandemic using Modular Validation Approaches

    For over three months the world has been battling COVID-19. COVID-19 is unforgiving and has the ability to overwhelm even the strongest health system or regulatory regime. Even though the...

    Learn More
  • Preparing for the Post COVID-19 Regulatory Environment

    Preparing for the Post COVID-19 Regulatory Environment

    Recently, the FDA Commissioner (Dr. Stephen Hahn) and the Director for the Center for Drug Evaluation (CDER) (Dr. Janet Woodcock) remarked that the very recently created Coronavirus Treatment...

    Learn More
  • COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials

    COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials

    Following successful completion of Phase 1 healthy subjects’ studies and animal challenge tests as discussed in Part 2, a number of strategies are possible to demonstrate vaccine efficacy. Such...

    Learn More
  • COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development

    COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development

    Clearly, the potential for vaccines to enhance rather than protect against infection through the two mechanisms of ADE and ERD discussed in Part 1, highlights the need for studies in animal models...

    Learn More
  • COVID-19 Vaccine Development - Part 1: Progress and Challenges

    COVID-19 Vaccine Development - Part 1: Progress and Challenges

    The enormous societal impact and global mortality, now over 150,000, that has resulted from the rapid spread of SARS-CoV-2, an enveloped RNA virus, underscores the criticality for accelerated...

    Learn More
  • ×

    Speak to one of our experts today

    First Name
    Last Name
    Company Name
    Title
    Country
    Tell us how we can help
    We'll be in touch shortly!
    Error - something went wrong!
  • loading
    Loading More...