The FDA has issued guidance to advise drug manufacturers how to resume normal manufacturing operations that were impacted by the COVID-19 pandemic, which has caused unusual challenges: employee illness and…
CDMO/CMO Expansion Update: Solid-Dosage Drug Products
Solid-dosage products continue to be a mainstay of new drug approvals. How are new drug approvals for solid-dosage products trending? Which CDMOs/CMOs are expanding in solid-dosage development and manufacturing with…
Which CDMO/CMOs of small-molecule or biologic-based APIs have announced or are making expansions thus far this year? Has expansion activity been greater in small molecules or biologics? DCAT Value Chain…
Small molecules continue to dominate approvals of new molecular entities (NMEs), accounting for approximately three-quarters of NME approvals over the past several years. What have been the small molecules approved…
FDA Inspections: Where do They Stand in Wake of COVID?
The FDA announced in July (July 2020) that it planned to resume “prioritized” domestic inspections and later issued a Q&A document to further explain how it is now handling inspections…
EMA Addresses Risk Mitigation for Nitrosamines Impurities in APIs
The European Medicines Agency (EMA) has issued a question-and-answer document to provide guidance on risk evaluation and mitigation of nitrosamines impurities in APIs and finished products with new requirements coming…
Clinical Trial Material Supply: The Impact of COVID-19
What has been the impact of the COVID-19 pandemic on clinical trials and thus supplying materials for these trials? DCAT Value Chain Insights takes an inside look and tracks the…
President Donald Trump issued an executive order late last week (August 6, 2020) to increase US-based production and federal procurement of essential medicines, medical countermeasures, and critical inputs. What does…
Reflecting the fallout from the COVID-19 pandemic, real GDP in the US decreased at an annual rate of 32.9% in the second quarter, and GDP in the eurozone shrank by…
Novel Excipients: Gaining Traction in the Industry
The FDA is considering a pilot program for the toxicological and quality evaluation of novel excipients. Excipients now are not separately reviewed by the FDA, and some say a separate…
