Regulatory submissions & planning

  • 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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  • 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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  • Rare Diseases: Aligning Expertise2:06

    Rare Diseases: Aligning Expertise

    See how Parexel are bringing together regulatory and market access experts to help companies developing rare and orphan disease products. Learn more about our Regulatory & Access Consulting Group: htt

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  • Parexel Regulatory & Access Overview Brochure

    Parexel Regulatory & Access Overview Brochure

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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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  • 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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  • 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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  • A Long and Winding Road for Transdermal Products – FDA Has It Covered

    A Long and Winding Road for Transdermal Products – FDA Has It Covered

    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...

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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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  • Parexel Biotech: The value of patient-centric approaches - escaping the clinic4:24

    Parexel Biotech: The value of patient-centric approaches - escaping the clinic

    Parexel’s Rosamund Round, Director, Patient Innovation Center and Amy McKee, Vice President, Regulatory Consulting Services sit down with Monica Theis, a breast cancer survivor and two-time clinical t

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  • New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...

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  • Regulatory Update: Patient Engagement in Drug Development

    Regulatory Update: Patient Engagement in Drug Development

    This month, the FDA released a draft of its second patient-focused drug development (PFDD) guidance document, detailing best practices for understanding patient experiences and the related...

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  • Strategies for Working with GRAs

    Strategies for Working with GRAs

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  • Case study condensed submissions

    Case study condensed submissions

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  • Case Study Global Regulatory Lifecycle Management

    Case Study Global Regulatory Lifecycle Management

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  • Regulatory Services Overview Infographic

    Regulatory Services Overview Infographic

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  • Brexit - the story so far

    Brexit - the story so far

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  • Using real-world evidence to help your product succeed

    Using real-world evidence to help your product succeed

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  • Regulatory Consulting Brochure

    Regulatory Consulting Brochure

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  • 3 Ways to Reap Benefits_Adaptive Trials

    3 Ways to Reap Benefits_Adaptive Trials

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