News & Analysis as of

Prescription Drugs › Federal Pilot Programs

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

Goodwin

Move Fast: FDA is Accepting Submissions for the Pilot Program Class for FDA Commissioner’s National Priority Voucher Program

Goodwin on

FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more

Hogan Lovells

New FDA pilot offers expedited drug program sponsors expanded FDA meeting opportunities on manufacturing issues

Hogan Lovells on

Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to provide...more

Mintz - Health Care Viewpoints

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

Mintz - Health Care Viewpoints on

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more

McDermott Will & Schulte

Modernizing FDA’s New Drugs Regulatory Program – Reviewing the Guidance Ecosystem and Implications for Life Sciences Companies

McDermott Will & Schulte on

In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more

Sheppard Mullin Richter & Hampton LLP

What’s in the Bottle? FDA Announces New Blockchain Pilot Program for Tracking Drug Distribution

Sheppard Mullin Richter & Hampton LLP on

Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a...more

Hogan Lovells

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

Hogan Lovells on

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request...more

Knobbe Martens

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

Knobbe Martens on

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management...

Robinson+Cole Health Law Diagnosis on

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more

Burr & Forman

Burr Alert: Part I: White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2017

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

Arnall Golden Gregory LLP on

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

Hogan Lovells

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide