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The Special Approval Pathway (SAP) for COVID-19 related products in China
The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005. SAP is...
Top 10 Myths About Working with the FDA for an Oncology Drug Approval
Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...
The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...
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...
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....
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...
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[1]. This biosimilar product, HLX01...
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...
