The Lachman Blog

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08
Jan

Big Year for NMEs at FDA

In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products.  All of the NME product approvals can be found here. It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on […]

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07
Jan

OGD November 2018 Stats Updated

Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions. November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA.  The OGD acknowledged […]

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06
Jan

Drug Pricing Issues and the Media Spin – Who Really Knows What the Answer Is?

I read four articles this morning that blamed high generic and brand name prices on everything from the confusion between list price and transactional pricing (here), to too much drug regulation (here), to PBMs and to the lack of negotiations between Medicaid and drug companies (here and here).  I am sure that there are many […]

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03
Jan

ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation – A Step towards Modernizing to Current Standards and Technology?

Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document. This is welcome news as ICH Q2(R1) is long overdue for revision (current […]

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02
Jan

Linaclotide Guidance Leaves BE Study with Clinical Endpoints as One Option but Also Provides for In Vitro Option as Well

Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration.  Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered.  Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) […]

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20
Dec

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

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18
Dec

Ricki Chase Publishes Article in MedTech Insight

Ricki Chase, Director, Compliance Practice, authored an article published in Medtech Insight, “How Device Makers Can Leverage FDA Data to Uncover The Agency’s Current Thinking on Compliance”. In this article, she discusses how manufacturers can use information available online from inspectional observations, warning letters, and product recalls to ascertain FDA’s priorities with regards to compliance […]

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18
Dec

Get the Government into the Manufacture and Distribution of Generic Drugs – Who Thought This One Up?

It looks like Senator Elizabeth Warren thinks it is a good idea! (see here!)  I think it is poppycock!  Just think of the problems we have now with drug shortages and recalls.  The stringent nature of the cGMPs and pharmaceutical manufacturing, in my opinion, do not lend well to government intervention.  What a conflict of […]

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14
Dec

OGD Ties Its 128 Approval Actions Record in November Plus October Stat Update

It appears that 128 is the magic number for the OGD as last month they also had 128 approval actions.  November numbers saw a different split between full approvals and tentative approvals (99 and 29, respectively).  The 128 total approval actions obviously ties last month record number of approval actions for a single month. Of […]

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