The Lachman Blog

31
Jan

FY 2022 GDUFA Science and Research Report – Impressive Findings and Conclusions

If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into.  The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for […]

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30
Jan

Petition Requests Removal of Generic Tasimelteon from the Market for Lack of Braille on Its Label

This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business!  The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda.  The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults.  The […]

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26
Jan

Breaking News – CBD Now Four Square on FDA’s Regulatory Radar and Agenda

After initial publication, this post was updated to provide links to the three petitions that FDA denied as mentioned above. https://www.regulations.gov/document/FDA-2020-P-1582-0005 https://www.regulations.gov/document/FDA-2022-P-0600-0005 https://www.regulations.gov/document/FDA-2019-P-5394-0004   The FDA has been struggling with the issue of CBD for quite a while. The use of CBD products in the marketplace has surged with CBD being claimed to be a […]

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26
Jan
Young man looks at road map near on mountain road, Switzerland

BsUFA III Roadmap Defined in Research Pilot Program

The biosimilars market is robust and, with continued progress, the savings to patients soar. According to FDA, there are currently 40 licensed biosimilar products and 3 interchangeable biosimilars, 24 of which are currently marketed. And since October of 2021, these products have captured between 3-89% of the market share, depending on the product. With several […]

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24
Jan

Investigations and Third Parties – Beware!

ICH Q10 (here) states the following as it relates to outsourcing activities and purchasing materials (hereafter referred to as third party): “The pharmaceutical quality system, including the management responsibilities described in this section, extends to the control and review of any outsourced activities and quality of purchased materials. The pharmaceutical company is ultimately responsible to […]

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23
Jan

FDA Guidance for Compounding Ibuprofen Suspension is in Effect Immediately!

With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]

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20
Jan

Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]

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