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FDA promotes user fee waiver options for combination products

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance...more

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more

FDA summarizes LDT rule requirements in new compliance guide

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more

FDA finalizes guidance on “Remanufacturing” vs “Servicing”

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more

Device makers must verify third-party lab data, FDA warns

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance...more

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more

FDA seeks greater LDT oversight and enforcement discretion phaseout by 2028

In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where the manufacturer of the IVD is a...more

Update to biocompatibility policy for medical devices in contact with intact skin

The U.S. Food and Drug Administration (FDA) published an updated final guidance on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk...more

FDA approving more Deep Brain Stimulation and Transcranial Magnetic Stimulation devices

While devices that stimulate the brain invasively have generally been available since 2002, and devices that do so non-invasively have been available since 2013, in recent years, the U.S. Food and Drug Administration (FDA)...more

FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more

Medical device 510(k) submissions must be electronic by October 2023, FDA says

The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to use FDA’s electronic...more

FDA delays UDI database enforcement for low-risk devices

On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a requirement that manufacturers of...more

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

COVID-19 Report for Life Sciences and Health Care Companies - December 2021

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA issues...more

COVID-19 Report for Life Sciences and Health Care Companies - November 2021

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: U.S....more

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

COVID-19 Report for Life Sciences and Health Care Companies - August 2021

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Wednesday's Report: U.S....more

Federal court limits FDA discretion in “drug” vs. “device” classification

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

In Tuesday's Report: FDA warns of false test results due to mutations, and authorizes new OTC tests; NY state clarifies paid vaccination leave law; and California requires COVID-19 paid sick…...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

STeP’ing up: FDA advances expedited device review program, set to begin in March

On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more

Final FDA combination product guidance encourages application-based feedback pathways

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it did in the draft version that “application-based...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more

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