- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
James Shehan, JD: FDA Guidance on Medical Product Communications
James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses the implications of recent FDA guidance on medical product communications.
Transcript
Recently FDA has changed its guidances on how companies can make communications about their drugs and devices. There [are] actually 2 separate categories: one is economic information, like, for example, is a drug cost effective or how does it say, reduce the length of hospitalization, what kind of money does that save. The other one goes into what kind of communications, what things that companies say that are consistent with the labeling of a product.
Both of these guidances essentially have slightly liberalized what companies can say by giving companies more guidance on what is permissible and what is impermissible. The healthcare economic one, in particular, companies really wanted to see because there have been 2 laws in the last 15 years where Congress asked FDA to do more in that area and give more guidance.
So that one is great now because now we know particularly prior to approval for example, that you can go and talk with payers and show more data about what has this product done in clinical trials.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
