The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...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
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
And employers will like it. NOTE FROM ROBIN: This is the text of a Legal Bulletin that we sent out today. I am posting it here for those of you who don't subscribe to our bulletins. The U.S. Equal Employment Opportunity...more
The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more
The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...more
On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers"...more
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more
Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more