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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law Blog: Biosimilars

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals. The ensuing Chemicals Strategy expounded upon the 1S1A concept further, presenting it as the definitive approach to heighten the efficiency, consistency, and transparency of European chemical regulation.

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Article EMA Thank You The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Why Nothing Can Grow on Mars*

Codon

The yeast cells synthesize lots of sugars to regulate their internal osmotic pressure and also attach sugars to proteins to stabilize them against damage caused by the perchlorates. A 58-page NASA report from 2006 arrived at a similar conclusion. Credit: Pacific Northwest National Laboratory / Paul Cannon.

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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda.

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