Generics

10
Sep
U.S. and EU Drug Shortages - Lachman Consultants

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight.  Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]

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06
Sep
Half full water glass over blue background

With a Snap of the Fingers – Just Like That, August Approvals Are Back in Business

At least unofficially, it appears the August 2024 approval numbers for ANDAs have popped back up.  As of the posting on the Daily approval listing (here) and the All approvals listing (here), there were 67 full approval actions, the second highest of Fiscal Year (FY) 2024 thus far, and 15 tentative approval actions. We will […]

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30
Aug
Something Wicked This Way Comes - Lachman Blog

Something Wicked This Way Comes?

For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]

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23
Aug
Businessman Signing Legal Paper In Office

New and Revised PSGs – Time to Check Your Portfolio!

Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here).  In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]

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20
Aug
Science versus Compliance - Lachman Blog

Science versus Compliance?

Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]

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