Manufacturers, Life Sciences, Comment Period

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on 3/26/2024

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

FDA on Board With Continuing Remote Inspections

Jones Day on 2/22/2024

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on 10/31/2023

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?

Stinson LLP on 8/23/2021

Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

Hogan Lovells on 7/27/2020

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on 8/8/2019

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

FDA Issues “Leapfrog” Draft Guidance for 3D Printing of Medical Devices

Morgan Lewis on 5/20/2016

3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more

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