Podcast: Non-binding Guidance: Breakthrough Devices Program
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
The U.S. Patent and Trademark Office (USPTO) has extended its pilot program for expedited review of COVID-19-associated patent applications to 30 June 2022. This is the third extension of the COVID-19 Prioritized Examination...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
Guidance Provides Roadmap for Companies Seeking Expedited Review of Products Aimed at Combatting SARS CoV-2 - In August, EPA issued a narrowly tailored approval under the Federal Insecticide, Fungicide, and Rodenticide...more
In welcome news for California health care facilities and providers, California SB-977, which would have required Attorney General approval for a broad range of transactions and other arrangements, did not pass in...more
To help food and beverage operators to maximise their capacity whilst complying with social distancing guidelines, the Bill introduces a fast track procedure for pubs, bars, restaurants and others selling food or drink for...more
Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more
On June 15, 2020, the United States Patent and Trademark Office (USPTO) announced a new program to provide prioritized examination for certain trademark and service mark applications that cover qualifying COVID-19...more
WLG has collaborated with members to present a series of meetings and workshops to connect and educate members during the month of May. The Life Sciences Group will host a webinar "International Regulatory Initiatives to...more
Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. ...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more