16
Mar

FDA Issues Draft Guidance with Definitions of Terms in Drug Supply Chain Security Act (DSCSA)

Today, the FDA issued a draft guidance titled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (here).  The various terms fall under the general areas identified in the DSCSA as Suspect Product and Illegitimate Product, and this guidance will help clarify how to further identify and […]

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15
Feb

CMS Wants to Balance the Cost of Drugs Approved through the Accelerated Process and It Has an Idea!

CMS realizes that some drugs approved through the FDA’s accelerated-approval process won’t prove to be safe and effective in final analysis.  It wants to balance its payment for products that might not pan out in confirmatory trials by trying to make firms sprint, rather than crawl, to finalizing such studies.  How?  Well, we know that […]

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10
Feb

Can Excess U.S. Production Capacity be a Key to Essential Medicines Production?

An AAM blog posted this morning (here), titled The Quickest Route to U.S. Essential Medicines Production: Existing and Idle Production Sites, seems to think that the answer to this post’s titular question is Yes, and it at least provides another option for consideration.  The AAM post cites a report (here) by Professor Anthony Sardella from […]

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09
Feb

As Ibuprofen Shortage Rages On, FDA Revises Recently Issued Guidance

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 […]

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07
Feb

Join Lachman Consultants at Access!™ AAM Annual Meeting 2023

Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023.  Access!™ is where policymakers, influential speakers and industry leaders […]

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06
Feb

January 2023 Unofficial Approval Actions and an Explanation!

As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals.  What the heck does that mean?  Well, let’s take an example from this month’s approval actions.  On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]

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