FDA Law Blog: Biosimilars

JULY 10, 2025

However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. If a drug is approved, section 916 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (codified at 21 U.S.C. §

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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

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Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

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Drug & Device Law

JULY 31, 2023

2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.” Buhimschi , 2007 WL 2902896, at *16 (E.D. 28, 2007), aff’d , 396 F. Henry , 2007 WL 2743097, at *2 (W.D.

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Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

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New Drug Approvals

APRIL 27, 2025

6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] 5] It works by causing the smooth muscle in the bladder to relax. [3]

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