Podcast: DeFi and Digital Assets: What do the UCC Amendments Mean for Business Transactions? [More with McGlinchey, Ep. 46]
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
Hospices and The False Claims Act: Proposed Amendment Would Increase Liability Risk
New Developments in the World of Section 230
Videocast: Asset management regulation in 2020 videocast series – The SEC’s proposed accredited investor definition
Videocast: Asset management regulation in 2020 videocast series – Private fund regulatory developments
Proposed FRCP Changes: Effect on eDiscovery, RIM & IG (CLE)
Pending proposals to amend China's Anti-Unfair Competition Law (AUCL) may further blur the line between antitrust and anti-corruption offenses under China's enigmatic "counterparty bribery" rules. The AUCL, first enacted in...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
A House committee will vote May 15 on an updated version of the BIOSECURE Act, legislation that would block federal contracts to five Chinese biotechnology companies and other drugmakers with certain China-based companies in...more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
On September 12, 2023, the Florida Board of Pharmacy published a notice of intent to adopt amendments to its rule on registered pharmacy technician-to-pharmacist ratios (64B16-27.410). The amendments would allow a supervising...more
The Arkansas House of Representatives proposed a bill that would amend the Pharmacy Practice Act to restrict pharmacy ownership to certain individuals and entities. The bill would require an applicant for a pharmacy permit to...more
UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more
During its August 31, 2022 meeting, the Kentucky Board of Pharmacy (“Board”) voted to move forward with the rule promulgation process for proposed amendments to 201 KAR 2:030. The proposed amendment will create a new...more
On May 3, 2022, the Texas Board of Pharmacy reviewed proposed amendments to its Central Fill Rule, 22 Tex. Admin. Code § 291.125, and voted to send the revised language for final adoption in the next Board meeting tentatively...more
On February 1, 2022, the Texas Board of Pharmacy voted to send proposed amendments to its Central Fill Rule under 22 Tex. Admin. Code § 291.125 back to staff for a redraft....more
On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more
Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more
Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
In response to the outbreak of a pneumonia-like disease caused by coronavirus (COVID-19), Chinese regulatory authorities adopted a few emergency measures under certain “Special Review and Approval Procedures” to fast-track...more
In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed...more
The OHIP+ program, also known as Children and Youth Pharmacare program, was implemented on January 1, 2018 by the Province of Ontario to provide free prescription drug coverage for all children and youth 24 years of age or...more
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes...more