Regulatory

11. Understanding The FDA's Current Focus On REMS 11/1/2023

    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.

12. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 11/1/2023

    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.

13. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    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.

14. 5 Best Practices For Responding To FDA Form 483 Inspection Observations 9/1/2023

    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.

15. State Scrutiny Of Drug Pricing Intensifies With Rise Of PDABs 8/1/2023

    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).

16. An Overview Of FDA Draft Guidance On “Manufacturing Changes And Comparability For Human CGT Products" 7/24/2023

    This article provides a detailed overview of The U.S. Food and Drug Administration's highly anticipated draft guidance to the industry that addresses “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.”

17. Insights Into The FDA's Guidance On Managing Drug Supply 7/3/2023

    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.

18. FDA's Digital Health Technologies Framework Addresses Important Challenges 7/3/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

19. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities 6/29/2023

    These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.

20. Securing FDA Expanded Access Designation For An Emergent Public Need 6/26/2023

    In this Q&A, SIGA Technologies Executive Vice President and Chief Scientific Officer Dennis Hruby discusses the journey toward expanded access, or compassionate use, of TPOXX and the importance of keeping a pulse on — and reacting to — an emerging public need.