News & Analysis as of

Physicians Draft Guidance

Arnall Golden Gregory LLP

All Mixed Up: FDA Issues Two Guidances Relating to Compounding Using Bulk Drug Substances

When we think of compounding, which is the process of combining, mixing, or altering ingredients to create a medication specific to the needs of an individual patient, we think of the Cars’ 1978 classic, “It’s All Mixed Up.”...more

Jones Day

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

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In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Alston & Bird

Alston & Bird Healthcare Week in Review

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On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more

Jones Day

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

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Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Foley & Lardner LLP

Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

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The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

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The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

Manatt, Phelps & Phillips, LLP

Health Update - November 2014

“Healthcare-Related” Calls: Ambiguity at the Intersection of HIPAA and TCPA - Editor’s Note: The Federal Communications Commission (FCC) has established exemptions from certain requirements of the Telephone Consumer...more

Foley & Lardner LLP

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

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Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Faegre Drinker Biddle & Reath LLP

What’s an MDDS? And Why Should I Care?

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

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