NDA Partners LLC, a consultancy of which I am a member, was featured in a news article in Business Worldwide.
The article notes that the pharmaceutical and medical device industry has the most complex regulations of any industry. They take at the unique consultancy services provided by NDA Partners.
The article notes: “…NDA Partners LLC, which provides product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide, has developed a new model of consultancy – the CDO or consulting and contract development organisation. And it’s a model that is entirely suited to small innovators and SMEs.” “NDA Partners distinguishes itself from other consultancies through its ability to assign top-tier expert consultants on all engagements. It provides the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization”
NDA Partners includes as consultants:
- Three former US Food and Drug Administration (FDA) Centre Directors
- Fourteen former FDA Director or Deputy Director Division heads
- The former Head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Three former EU regulatory agency senior staff
- The former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP)
- Dozens of highly experienced former biopharma and medical device industry executives
In the 10 May 2019 issue of Science magazine, Assistant Professor of the University of Florida, Alan H Chambers, writes about his experience with a predatory journal. In a moment of weakness after rejection of a manuscript, he submitted it to a newly launched journal. It turns out it was a “predatory journal” in all aspects of the phrase. He realized his mistake and requested it be withdrawn. With a quality journal, this would be honored immediately. This journal demanded payment. Only with repeated demands from the University was the paper “let go”. The author also suggests ways to test a journal (e.g., look at the editorial board, contact them separately to confirm, etc.). Moral of the story – the pressure to publish are real – but don’t succumb to submitting to these journals.
At the 3rd Annual Sonoma Eye, meeting, Dr. Novack chaired a symposium on two areas of interest – basic research in ocular inflammation and retinal disease and clinical outcomes. Dr. Novack presented current thinking on endpoints in approvals of novel therapeutics in ophthalmology. He also moderated the discussion on how to best use pre-clinical models to aid in drug development. Including Dr. Novack, there were 3 speakers from the University of California, Davis.
Pinterest recently stated that “..it would no longer return any search results, including pins and boards, for terms related to vaccinations, whether in favor or against them.” The firm noticed the majority of shared images on their site cautioned people against vaccinations. As I wrote in an article in 2017, “Anti-Science in the 21st century”. we have a safe, effective, affordable prevention of a terrible disease. Use it!
The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.