Podcast: Non-binding Guidance: Breakthrough Devices Program
The Massachusetts Affordable Homes Act (H. 4977), signed into law on August 6, 2024, makes several revisions to G.L. c. 185 that will streamline the processes for deregistration and correcting minor mistakes on certificates...more
As part of Mayor Eric Adams' "Get Stuff Built" initiative to increase housing supply and reduce regulatory constraints on new development, the New York City Planning Commission approved the Green Fast Track for Housing Rule...more
Some significant planning changes are proposed in a government consultation on ‘An Accelerated Planning System’ launched on 6 March 2024 alongside the Spring Budget (which closes on 1 May). These proposed changes cover new...more
Results Show Leadership Prioritization and Sufficient Resources Among Factors Contributing to High Timeliness - WASHINGTON – The U.S. Equal Employment Opportunity Commission (EEOC) today issued a report titled “Timeliness...more
The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more
The Government’s Action Plan on how it proposes to improve the NSIP planning process has some good ideas, most of which amount to fine-tuning rather than a fundamental change. Whilst some of the changes may increase the cost...more
The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, “Cancer Moonshot Expedited Examination Pilot Program” (the “Cancer Moonshot Program”)...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
YIMBY et al. v. City of Los Angeles et al. concerned a proposed 67-unit housing development in the Woodland Hills area of the San Fernando Valley. While the City of Los Angeles's (the City) general plan designated this area...more
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
If you have applied for an immigration benefit lately (temporary visa, permanent residence), you know the indignities of the process - especially in recent times. Slower decisions, outlandish requests for evidence, and no...more
On January 1, 2020, several housing-related bills recently signed into law by the Governor take effect. We will explain the upcoming changes in housing law through a series of updates. Our first update provided information...more
Ahead of the January 1, 2020 effective date for several housing-related bills recently signed into law by the Governor, we will explain upcoming changes in housing law through a series of updates. Our first update provided...more