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FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims...more

New Jersey Bans and Caps Certain Manufacturer Gifts and Payments to Prescribers

On January 16, 2018, New Jersey’s new regulations limiting gifts and payments from prescription drug and biologics manufacturers to prescribers were issued in the New Jersey Register and became effective. After receiving...more

FDA 2017 Year in Review

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Cannabis Chaos: Justice Department Revokes Obama-Era Guidance on Marijuana Enforcement

On January 4, 2018, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance...more

FDA Issues Fourth and Final Software as a Medical Device Clinical Evaluation Guidance

The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more

FDA Publishes Draft Guidance on CDS Software and Revises Medical Software Policies

On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more

FDA Issues Final Drug and Device Classification Guidance

This week, the FDA published final guidance outlining the agency’s current thinking with respect to the classification of products as drugs or devices, respectively. The final guidance summarizes the agency’s position with...more

9/29/2017  /  FDA , FDCA , Final Guidance , Life Sciences

New Maine Law Limits Manufacturer and Wholesaler Interactions with Health Care Professionals

Maine recently amended its Pharmacy Practice Act to prevent licensed manufacturers or wholesalers and their agents from offering or giving certain gifts to practitioners. The bill’s sponsor tied the issue of gifts from...more

FDA’s Delay of the Menu Labeling Rule Challenged

Two consumer advocacy groups recently sued the Food and Drug Administration (FDA) for delaying the compliance deadline for the agency’s 2014 menu labeling rule for a fourth time. The menu labeling rule requires menu items...more

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more

FDA 2016 Year in Review

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

The Trump Administration’s View on Marijuana: Reading the (Tea) Leaves

The incoming Trump Administration may usher in a more hostile climate to state efforts to legalize the sale and distribution of marijuana and products that contain the drug. The Obama Administration opposed the federal...more

21st Century Cures: Food and Drug Administration (FDA) Drug Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

21st Century Cures: Examining Medical Device Provisions

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

21st Century Cures: Examining Provisions for Streamlining FDA Regulations for Clinical Research in Title III

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws

This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps...more

FDA Delays Enforcement of Restaurant Menu Labeling Rule

This week, the Food and Drug Administration’s (FDA) Director of the Center for Food Safety and Applied Nutrition (CFSAN) formally announced that the agency will delay enforcement of its final rule entitled “Food Labeling;...more

Ohio Court of Appeals Upholds a Successor Manufacturer’s Termination of a Distribution Franchise

The “successorship” provision of Ohio’s franchise law for alcohol beverages has spawned much litigation over the past two decades. Premium Beverage Supply, Ltd. v. TBK Production Works, Inc. represents the latest chapter of...more

FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel...more

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

New HIPAA Privacy Rule Permits Disclosures to Background Check System

On January 6, 2016, the U.S. Department of Health and Human Services (HHS) issued a final rule amending the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen the current background check...more

1/14/2016  /  Disclosure , Firearms , HHS , HIPAA , Mental Health , NICS , PHI , Popular

Update: FDA Extends Comment Period for Input on Uses of “Natural” in Food and Beverage Labeling

On December 28, 2015, the U.S. Food and Drug Administration (FDA) extended by 90 days the public comment period on the use of the term “natural” in food and beverage labeling. As discussed in an earlier post, the FDA is...more

FDA Releases Guidance on Voluntary Labeling for Foods Derived from Genetically Engineered Plants

On November 23, 2015, the U.S. Food and Drug Administration (FDA) issued a guidance to assist food and feed manufacturers that would like to label their plant-derived food products or ingredients as produced with or without...more

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