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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

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. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

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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Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

Section 2008 Improved Consumer Confidence Reports amended the Safe Drinking Water Act section 1414(c)(4) to revise requirements for Consumer Confidence Reports (CCR). EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS. These areas include Dallas-Fort Worth, TX, Denver-Boulder-Greeley-Ft.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. This scenario was the “third hypothetical” in our “ Learned Intermediary Rule 201 ” post back in 2008. 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. . . .

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How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

2008 WL 11344752, at *2 (D. April 22, 2008); Isham v. 2008 WL 2622791, at *4 (N.D. July, 1, 2008) (“provision of a manual for software does not convert the transaction from one for a software service to one for both tangible goods and service”). 2008) (all quoting and following Pierson definition of product).

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D. Arizona Precludes Pelvic Mesh Punitive Damages

Drug & Device Law

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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Flurpiridaz F 18

New Drug Approvals

2008 ; Nagel 2014 ) Briefly, to a mixture of mucochloric acid ( 1 ) (1.18 This article incorporates text from this source, which is in the public domain. ^ “Drug Approval Package: Flyrcado Injection” U.S. Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 25 October 2024.

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