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
Texas AG Ken Paxton has launched a coalition and pilot program to help Texas students dispose of unused opioids safely and conveniently. Called the “Friday Night Lights Against Opioids” program, the coalition will distribute...more
California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a “stewardship plan” to CalRecycle, a branch of the state’s Environmental...more
The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more
Misuse of controlled substances continues to be a serious public health problem in the United States. The most commonly misused controlled substances include opioids (such as oxycodone), which are used to treat pain, and...more
The United States Environmental Agency (“EPA”) released December 19, 2019 interpretive guidance titled: Manifesting Non-Creditable Hazardous Waste Pharmaceuticals – New Four Character Code (“Guidance”) - The document...more
The U.S. Environmental Protection Agency’s final rule governing management of hazardous waste pharmaceuticals became effective August 21, 2019. The new regulations apply to the management of hazardous waste pharmaceuticals by...more
Earlier this year, the Environment Protection Agency (“EPA”) adopted a final rule imposing new standards for the management of hazardous waste pharmaceuticals (“HWPs”) that goes into effect on August 21, 2019 (“Final Rule”)....more
Certain pharmaceuticals are regulated under the Resource Conservation and Recovery Act (RCRA) as “hazardous waste” when they are discarded. EPA recently finalized new management standards for hazardous waste pharmaceuticals...more
On February 22, 2019, EPA published its final rule governing standards for the management of pharmaceutical hazardous wastes in the Federal Register (Final Rule). The Final Rule’s publication in the Federal Register sets...more
On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent...more
Barnes Johnson, Director of the United States Environmental Protection Agency (“EPA”) Office of Resource Conservation and Recovery (“RCRA”) authored a September 11th memorandum titled: Management of Household...more
The California Senate enacted Senate Bill 212 (SB 212) which would create a statewide drug and needle take-back program. SB 212 would require entities that sell drugs or sharps in the state of California to individually...more
The State of New York enacted a law that requires certain manufacturers to operate a drug take back program. The Act signed into law by New York Governor Cuomo is denominated the “Drug Take Back Act” (“Act”). ...more
Governor Cuomo signed into law on Tuesday, July 10, 2018 the New York State Drug Take Back Act (“Act”). New York joins the State of Washington as the first two states to adopt statewide drug take back programs for unwanted...more
The national opioid crisis has led politicians and law enforcement to increase their focus on the regulation of controlled substances. Hospitals and other facilities should ensure that they are compliant with DEA rules on not...more
On March 22, 2018, the Governor of the State of Washington signed the Secure Drug Take-Back Act, which establishes the first statewide drug take-back program in the nation. The Act requires manufacturers of “covered drugs”...more
The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more
On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more