Carolyne Hathaway at Latham & Watkins LLP

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

12/3/2018 / 510(k) RTA , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda

FDA Issues Draft Guidance on Orphan Drug Designation in Pediatric Subpopulations

New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more

12/22/2017 / Draft Guidance , Food and Drug Administration (FDA) , Orphan Drugs , Pediatrics , Pharmaceutical Industry

FDA Issues Draft Guidance on Biosimilar Interchangeability

Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” - On January 18, 2017, the US Food and Drug Administration (FDA or...more

1/27/2017 / Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Interchangeability , Pharmaceutical Industry

Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity

Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests. As the Food and Drug...more

9/22/2014 / Biologics , BPCIA , Food and Drug Administration (FDA) , PHSA , Product Exclusivity

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

8/21/2014 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Medicare , Reimbursements

Unapproved New Uses: FDA Revisits Policies on Distributing Scientific Publications

In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices. On March 3, 2014, the Food and Drug Administration (FDA) released a...more

3/18/2014 / Food and Drug Administration (FDA) , Off-Label Use , Pharmaceutical Industry , Prescription Drugs

A Look at the FDA’s New Social Media Guidance

Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age. On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more

2/14/2014 / Advertising , Food and Drug Administration (FDA) , Pharmaceutical Industry , Social Media

FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages

Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action. The US Food and Drug Administration (FDA or...more

2/6/2014 / Dietary Supplements , Food and Drug Administration (FDA) , Food Labeling

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

12/10/2013 / Biologics , Food and Drug Administration (FDA) , Life Sciences , Patents , Pharmaceutical Industry , Prescription Drugs

Preparing for a "New Era of Medical Product Development"

FDA report demonstrates support for personalized medicine and more efficient regulatory pathways. In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more

11/8/2013 / Food and Drug Administration (FDA) , Medical Devices , Personalized Medicine

Carolyne Hathaway

Latham & Watkins LLP

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