Drug Shortages

10
Jul
Agency and Industry Discuss Drug Supply Chain Policy Solutions - Lachman Blog

Agency and Industry Discuss Drug Supply Chain Policy Solutions

Did you ever REALLY wonder what is being done by our federal government and other stakeholders to combat the current drug shortage situation? This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium (with yours truly participating on the expert panel) met to […]

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06
Feb
Information for the mass

More Info from the AAM Annual Meeting Regulatory and Policy Meeting

During her session yesterday at the AAM Annual Meeting, Iilun Murphy, M.D. provided additional details on the 2023 OGD metrics, indicating that there were 950 ANDAs approved and tentatively approved (782 and 172 approvals, respectively).  Of the approvals, there were 90 first generics, along with 83 generics with Competitive Generic Therapy Designation, and 111 complex […]

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16
Jan
Headline shortages

Just When You Thought the Lisdexamfetamine Shortage Was Over, the Capsule Product Takes Another Hit 

Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs (here) that we believed would mitigate the ongoing shortage.  Today, however, the FDA reported (here) that Lisdexamfetamine capsule dosage-form products are in trouble again.  On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of […]

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25
Oct
Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]

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09
Jun

Supply Chain Risk and Data Management Poised to Take a Leap Forward

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 […]

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05
Apr

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

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 […]

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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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