Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
The Supreme Court of California is gearing up to decide an important question for the future of product liability law: Do drug manufacturers have a duty to innovate? In other words, does a manufacturer of a non-defective drug...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
Given its growing role as the “pharmacy to the world,” FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's) views upon his return. During his visit, Commissioner Califf met...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
On April 27, 2021, the United States Tax Court held that legal fees incurred by generic drug manufacturers in connection with “Section 271(e)(2)” patent infringement suits are deductible as ordinary business expenses and need...more
The Federal Circuit’s October 2020 split decision in GSK v. Teva made waves throughout the pharmaceutical industry and among Hatch-Waxman litigators. In the broadest reading, some see the majority opinion as rendering any...more
On Wednesday, July 15, the House Energy and Commerce (E&C) Committee advanced several bills to the House floor that demonstrate continued interest in health policy matters other than the COVID-19 pandemic. The Fairness in...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more
With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Today, the Massachusetts Supreme Judicial Court made an important ruling concerning innovator liability with respect to pharmaceuticals. Though precluding negligence and traditional product liability claims against brand-name...more
On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more
President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more
On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more
In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more