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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
Parexel Regulatory & Access Overview Brochure
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...
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...
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...
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On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...
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. This biosimilar product, HLX01...
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
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...
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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