The Lachman Blog

26
Jan

Webinar on FDA Incentives Features Compliance Expert

Next Wednesday’s free webinar from Lachman, “FDA Incentivizing Organizational Maturity to Drive Product Quality,” will be hosted by Lachman’s Vizma Carver, M.S. In this 90-minute session, she will dive in on the FDAs efforts to utilize incentives to drive product quality. As someone who used to work at the FDA, Ms. Carver is uniquely positioned […]

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25
Jan

Compliance/Enforcement Activity, the Slow Down, and Predictions

Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry.  COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry.  High […]

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22
Jan

MEDICAL DEVICE WEEK – A LACHMAN LEARNING EXPERIENCE – FEATURES WEBINAR ON FDA QUALITY INCENTIVE PROGRAMS

The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) […]

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20
Jan
Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

You Just Can’t Go a Week Without Seeing FDA Action on an ED or Weight Loss “Supplement”

So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over?  This is not a new problem.  We have posted about it numerous times here, here, […]

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19
Jan

Outlining COVID-19 Safety Expectations for ANDA BE Studies

On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”.  This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency.  As is no surprise, FDA clearly […]

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13
Jan

Statutes and Regulation Verses Reality – Is Transparency the Key?

While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed.  The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]

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12
Jan
How did that happen?

So Now We Know Why the OMUFA User Fee Notice Was Withdrawn

The confusion regarding the initial publication of the OTC User Fee Act announcing the user fee structure originally published here and its subsequent withdrawal published here is (for the most part) clarified now by the January 12, 2021 FR Notice here that identifies the issue precipitating in the withdrawal. In the current FR Notice, the […]

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