Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more
Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more
The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more
On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more
On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more
FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides...more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices,...more
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...more
The Third Circuit recently held in In re Remicade (Direct Purchaser) Antitrust Litigation that a direct purchaser’s antitrust suit alleging overpayment for a drug purchased pursuant to a distribution agreement with a...more
During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more
Regulations adopted by the New Jersey Attorney General Division of Consumer Affairs titled LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS became...more
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more
Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more
A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more
A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more