REGULATORY ARTICLES

• Understanding And Navigating Diverse Regulatory Environments

  Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

• A New Year’s Resolution Suggestion For The FDA

  Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

• Trends In Next-Generation Delivery Technologies

  Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

• Understanding The FDA’s Current Focus On REMS

  Our Life Science Connect sister publication, Bioprocess Online, asked Linda Pissott Reig, an attorney at Buchanan Ingersoll and Rooney, to explain more about why the FDA is focusing on safety programs for drugs with high-risk profiles and what it means for drug companies that have REMS products in their portfolios.

• An Overview Of The 9 FDA Special Designations For Pipeline Drugs

  The FDA employs various special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and biologics license applications (BLAs), others may abbreviate the duration of clinical trials.

• FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don’t Mistake It For An Enforcement Delay

  On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

• 5 Best Practices For Responding To FDA Form 483 Inspection Observations

  How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.

• State Scrutiny Of Drug Pricing Intensifies With Rise Of PDABs

  More than five years after state price transparency laws began spreading throughout the country, states have opened up a new front in their battle against what they deem to be excessively high prescription drug prices through the establishment of prescription drug affordability boards (PDABs).

• An Overview Of FDA Draft Guidance On “Manufacturing Changes And Comparability For Human CGT Products"

  This article provides a detailed overview of The U.S. Food and Drug Administration's highly anticipated draft guidance to the industry that addresses “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.”

• Insights Into The FDA’s Guidance On Managing Drug Supply

  This new guidance describes the scope to include both permanent discontinuances as well as temporary interruptions in the manufacture of drugs including biological products and blood and blood-derived products.