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Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more
The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more
Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more