Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...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 October 19, 2023, the Ontario Ministry of Health proposed regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to align Ontario’s requirements for...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
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
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
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
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
On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more
On May 3, 2019, two sets of proposed amendments to the Food and Drug Regulations were published: The proposed amendments contain provisions which would streamline the process for providing access to unauthorized drugs for...more
PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...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
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
Gilead prevails in SOVALDI appeal - The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and...more