News & Analysis as of

The United States Food and Drug Administration Center for Disease Control

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Trump Administration Releases Fiscal Year 2018 Budget Proposal

by Baker Donelson on

On Tuesday, May 23, the White House released the President's fiscal year 2018 (FY18) budget, launching a contentious and consequential debate that is expected to last through the end of the fiscal year and possibly beyond....more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

Food and Beverage News and Trends - April 2017

by DLA Piper on

Six consumer groups ask major food companies to oppose regulatory reform bill. On April 11, a coalition of six consumer organizations sent a letter to 11 major food manufacturers, retailers and restaurant chains, calling upon...more

FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

by Knobbe Martens on

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary...more

Uncertainty rises about leadership in nation’s top health posts

Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this...more

Bacteria Found in Cardiac Patients Linked to Heater-Cooler Machine

Heater-Cooler Machine Spreads Germs in Sterile Areas - The medical device sounds well-intended enough: a heater-cooler machine used during heart surgery to control a patient’s body temperature. Doctors employ them in the...more

Food and Beverage News and Trends - October 2016

by DLA Piper on

FDA seeks public comment on possible revision of its definition of "healthy" on food labels. The FDA has begun an initiative to revisit its legal definition of "healthy" as used by manufacturers on food labels. In a September...more

Contaminated Flour – Is Nothing Sacred?

by Selman Breitman LLP on

As of August 1, 2016, General Mills had voluntarily recalled some 45 million pounds of several types of raw flour products because E.coli bacteria had allegedly been found in flour produced at the General Mills plant in...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

Will Congress vaporize proposals to curb tobacco use, protect kids’ health?

Just days after federal health officials warned about teen-agers’ increasing use of e-cigarettes (vaping) and hookahs, members of a House committee have approved a legislative move that shields vaping manufacturers from...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

Food and Beverage News and Trends Series - April 2016

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Four major companies announce voluntary GMO labeling. Four major food...more

Four Distinct Federal and State Policies Addressing Prescription Opioid Abuse

by Foley & Lardner LLP on

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

FDA Takes Further Steps to Curb Opioid Abuse

by McDermott Will & Emery on

Required Black Box Warnings on Immediate Release Opioids - Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food...more

Federal Rx for Opioid Epidemic: Tighten Rules on Prescribers

by Faegre Baker Daniels on

The federal government has made no secret of its concern over what is invariably described as an “opioid epidemic” sweeping the country. Nor is it a secret that the government sees prescribing physicians—especially primary...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Food and Beverage News and Trends - March 2016

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Senate confirms new FDA commissioner. On February 24, the US Senate confirmed,...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Opioid Use on Front Burner at FDA Now That Congress Has Intervened

The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers....more

FDA Unveils Action Plan to Combat Opioid Abuse

by Foley & Lardner LLP on

The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

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