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
On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear." At...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As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
From the moment a new invention or technology is realized, the race to patent the invention has begun. Anyone can apply for a patent to protect their inventions, discoveries and technologies at the U.S. Patent and Trademark...more
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
The USPTO has issued proposed rules to make permanent a Covid-19-related change in the manner in which applications for patent term extension under 35 USC § 156 are to be filed. While the Covid-19-related changes permitted...more
Nicki Kennedy -- a Kilpatrick Townsend partner who is a registered patent attorney concentrating her practice on patent-related matters with a focus on client counseling, patent prosecution, domestic and international patent...more
Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine. Allele holds a patent for a...more
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...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
On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars: First, Section 322 of Division BB permits but does not require aBLAs to include information...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more
This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more
After offering to expedite review of trademark applications for COVID-19 products and services, the USPTO has now launched a prioritized examination pilot program for certain patent applications “that claim products or...more
The USPTO has authorized an initiative to prioritize examination of patent applications having COVID-19 uses that would require FDA approval. A pilot program only for small and micro entities has been implemented effective...more
The United States Patent and Trademark Office has established a new program for prioritized examination for patent applications for inventions related to COVID-19 and for trademark applications for marks used for certain...more
Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more
Starting in May of 2020, the United States Patent and Trademark Office (U.S. Patent Office) has initiated a pilot program for prioritized examination of non-provisional patent applications which cover inventions related to...more
Small business efforts to patent technology which deals with the COVID-19 outbreak will be getting a boost thanks to the United States Patent and Trademark Office (USPTO)...more
The United States Patent and Trademark Office (USPTO) has introduced a pilot program to provide prioritized patent examination for patent applications that cover a product or process related to COVID-19. The product or...more
The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides...more
On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new program for expediting certain COVID-19 related patent applications. Under the COVID-19 Prioritized Examination Pilot Program, the USPTO...more
On May 8, 2020, the United States Patent and Trademark Office (US PTO) announced a new COVID-19 Prioritized Examination Pilot Program. The new pilot program provides an expedited prosecution of COVID-19-related patent...more
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of declaration” conferring broad-based immunity from tort (including product liability) litigation for...more