The Lachman Blog

12
May

Amendment to User Fee Legislation to Expedite Some Generics and Suitability Petitions

Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill.  However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective. The Amendment, which was paired […]

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27
Apr

GMP Inspection Deficiency Data Trends for 2016 – Who is Minding the Store?

With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes. If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues […]

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25
Apr

Can You Believe This?  Unfortunately, It Seems to Be the Norm!

The FDA announced today that it issued Warning Letters to 14 companies for selling unapproved cancer treatments ranging from thermal devices to creams, ointments, syrups, teas, and various pills.  Life is too short to have charlatans trying to steal precious chances for life from cancer patients.  While I am glad that the FDA has acted, […]

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24
Apr

MHRA GMP Inspection Deficiency Data Trend 2016

The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation  can be found here. In comparison to 2015, the MHRA increased […]

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