Parexel Blog
Parexel Blog
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Learn MoreHow the UK's HTA Agency Uses Real-World Evidence to Develop Guidance
The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...
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Learn MoreIt’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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Learn MoreNDA 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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Learn MoreBetween Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities
In January 2020 the Food and Drug Administration (FDA or “agency”) published the revised draft guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing...
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Learn MoreEpidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study
A Lancet article
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Learn MoreBeware 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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Learn MoreFDA 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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Learn MoreCan 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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Learn MoreRare 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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Learn MoreCritical 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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Learn MoreDoes 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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Learn MorePress announcement: Parexel unveils combined Regulatory & Access consulting organization
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Learn MoreReimagining The Global Value Dossier - Part 6
A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...
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Learn MoreWill 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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Learn MoreDon’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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Learn MoreNew PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management
On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...
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Learn MoreCommercial 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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Learn MoreHow to align your market access activities with your product value strategy
The value strategy (also termed value story) for your product should act as the cornerstone for all market access activities. The value strategy drives your market access planning, which...
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Learn MoreA 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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Learn MoreDemystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...
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