Contentious FDA Controversies in 2018
In a sense, FDA regulations are a game of political football. The goal posts are always moving. As new administrations come in, so do new administrators. The current year is no different, with a number of areas shaping up to be contentious points with regard to FDA approvals.
- Generics: First generics have long been a controversial issue among regulators. In theory, the FDA always wants to speed up approvals process to get first generics on the market. However, in practice, many manufacturers are unhappy with the process.
- Lab-Developed Tests: Lab-developed tests (or LDT regulation) closely parallel the debate around generics. Both seek to balance patient safety with getting new drugs to market in a timely fashion.
- Patient Advocacy: Patients with chronic and terminal conditions always want faster approvals for palliative care. The FDA wants to provide this, but without sacrificing its role as a consumer protection agency.
- International Collaboration: The FDA’s regulations cover products made in more than 150 different nations in an increasingly global market. Domestic organizations must play a bit of catch up in terms of regulatory oversight.
These are just some of the current controversies surrounding FDA approvals. We discuss these and others in more detail in our recent white paper. It’s important to partner with a CRO abreast of current internal FDA debts so that you know what to expect during Phase Three.
Our next blog article will discuss how your partners might fail to understand regulations and the impact it can have on the approval process for you.
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