Providing Scientific Stewardship to the Healthcare Industry and Counsel.
The commercialization of biosimilars was enabled by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 which was signed into law on March 22, 2010 as part of the Patient Protection and Affordable Care Act. Read more
![Opioid Litigation – The Defense Perspective [Download Conference Presentation Slides]](https://innovativescience.net/wp-content/uploads/2020/09/tabs_pkg_insert.jpg)
The opioid litigation landscape continues to evolve, with over 200 lawsuits currently consolidated in the multidistrict litigation (MDL), In re: National Prescription Opiate Litigation, MDL No. 2804, in the Northern District of Ohio and being overseen by U.S. Read more
Key Opinion Leaders (KOLs) are physicians and scientific experts that have an independent voice or strong impact earned from an established reputation in their field. Read more
A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community. Read more
It’s likely that most readers of this blog, let alone most members of the public, have little idea of what the Ingelfinger Rule is and less about why it is so important. Read more
On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application. Read more
On March 8th, 2018 the FDA Gastrointestinal Drugs Advisory Committee (GDAC) discussed the supplemental new drug application (sNDA) Read more
Whether you are outside counsel retained in a pharmaceutical product liability case or in-house counsel responsible for a chemical manufacturer in a high-profile government investigation, having the right regulatory expert can be the difference between remarkable success and high stakes failure. Read more
A recent defense verdict in the testosterone litigation highlights the importance of genetics in pharmaceutical litigation. Read more
On February 14th, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Read more
Each year, adverse drug events cost millions of dollars in hospital admissions, injuries to patients, and malpractice. Read more
This post was authored by David H. Schwartz, a principle at Innovative Science Solutions and Paul Fehlner, JD, PhD, founder of Life Sciences Innovation. Paul is a life sciences lawyer and biopharmaceutical consultant with a strong intellectual property focus who partners with research institutes, startups, and Fortune 500’s to help them transform basic scientific discoveries into life-changing products and services around the world. Read more
As a litigator specializing in product liability, toxic torts, government actions and other civil litigation, identifying the right experts and recruiting a team of experts perfectly suited to your case can be critical to your success, especially when that case involves complex scientific issues. Read more
The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. Read more
The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP). Read more
Human-Organs-on-Chips are microfluidic cell culture microchips lined with living human cells that simulate the functions of human organs, including the lung, intestine, kidney, skin, bone marrow and blood-brain barrier. Read more
The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations. Read more
This post was drafted by Innovative Science Solutions and Wendell S. Fortson, founder of Fortson Strategies, LLC. Fortson Strategies is a national cancer litigation strategy firm for corporations. Read more