Today, the Association for Accessible Medicines released a White Paper (here) that provides their views of the factors that may cause drug shortages and also provides some reasoned solutions to reduce and help prevent future drug shortages. While the white paper does indicate that the number of shortages has decreased somewhat over the past few […]
In a complete supply chain, one site’s lag measure is another site’s lead measure. As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients. As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]
The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]
On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]
FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list. The current list (here) contains 343 entries Most products have had their expiration dates extended by one year from the labeled expiration date. The list provides information to providers to verify that the firm had submitted […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem. Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy. There has even been one firm created […]
