Searching Content indexed under Food and Drugs Law by Day Pitney LLP ordered by Published Date Descending.
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CMS Seeks Relaxation Of Kickback & Self-Referral Regulations
The CMS recently published proposed changes to the Anti-Kickback Statute and Stark Law to address concerns that these laws are too restrictive and not current with modern healthcare and therefore are stifling innovation ...
United States
7 Jan 2019
FDA Announces Regulation Of Biopharma Apps
The FDA recently published a Notice and Request for Comments regarding a potential proposal to impose less stringent regulations on biopharmaceutical software applications, signifying an area of growth for digital health technology.
United States
7 Jan 2019
New CMS Rule Bolsters MA And Part D Negotiations With Drug Manufacturers
On November 26, 2018, the CMS proposed a new rule aimed at lowering the cost of prescription drugs and out-of-pocket expenses under Medicare Advantage and Part D prescription plans.
United States
7 Jan 2019
New Jersey Poised To Legalize Recreational Cannabis Use, But Federal Criminal Prohibition Remains In Place
The Act would legalize under state law the possession and use of one ounce or less of cannabis by persons 21 years of age or older.
United States
10 Dec 2018
Physicians And Teaching Hospitals Received $8.4 Billion In Payments In 2017
This number represents a slight decrease from the $8.81 billion in payments reported in program year 2016.
United States
9 Jul 2018
FDA Releases Long-Awaited Off-Label Guidance
FDA Releases Long-Awaited Off-Label Guidance.
United States
14 Jun 2018
Yet Another Delay For 340B Drug Pricing Program Rule
On June 5, the Health Resources and Services Administration, part of the U.S. Department of Health and Human Services, published a final rule that further delays the effective date of the January 5, 2017 ...
United States
6 Jun 2018
Proposed NJ Bills Would Relax Rules For Nurses Prescribing Meds
Two new bills introduced by Assemblywoman Nancy Munoz for review by the New Jersey State Assembly's Health and Senior Services Committee would give registered nurses more autonomy in prescribing medications.
United States
26 Apr 2018
The President May Support Future Federal Legislation To Protect The State-Sanctioned Cannabis Industry
The President's decision ends a legislative blockade imposed by Gardner which has prevented the confirmation of 20 nominees to fill various positions within the Department of Justice.
United States
18 Apr 2018
The Potential Legalization Of Cannabis In New Jersey: Real Estate Considerations
The likelihood of legalization of cannabis in New Jersey under state law necessitates the consideration of many legal issues.
United States
21 Mar 2018
A Provider's Guide To Managing A Medical Device Recall
While manufacturers are generally responsible for initiating medical device recalls, providers are usually best positioned to identify and notify affected patients and quarantine identified devices.
United States
22 Feb 2018
White Collar Roundup - February 2018
As reported here, here and here, the National Association of Criminal Defense Lawyers (NACDL) has been in hot pursuit of the litigation manual of the U.S. Department of Justice (DOJ), known as the "Blue Book."
United States
7 Feb 2018
Revised DEA Rule Addresses Opioid Crisis
On January 23, the U.S. Drug Enforcement Administration (DEA) announced that it has expanded the types of licensed providers allowed to prescribe the narcotic drug buprenorphine for opioid addiction.
United States
30 Jan 2018
Sessions Issues Memorandum On Federal Marijuana Enforcement Policy
On Thursday, January 4, the United States Attorney General Jeffrey Sessions issued a memorandum on federal marijuana enforcement policy (Sessions Memo).
United States
9 Jan 2018
CMS Announces Expansion of Medicare Advantage V-BID Model
On November 22, the Centers for Medicare & Medicaid Services (CMS) announced that the Medicare Advantage (MA) value-based insurance design (V-BID) demonstration project will be expanded in 2019 to an additional 15 states, and more options will be made available to participants.
United States
23 Nov 2017
Justice Dept. Mulling Yates Memo Policy Clarifications
An October 17 article in Bloomberg BNA's Health Care Daily Report and other publications, "Justice Dept. Mulling Yates Memo Policy Clarifications," discussed the U.S. Department of Justice's (DOJ's) planned review of the so-called Yates memo. Day Pitney's Eric Fader was quoted in the article.
United States
20 Oct 2017
HRSA Further Delays Final Rule On 340B Drug Pricing Program
Implementation of the final rule, originally released in January and previously discussed here, had already been postponed three times this year, most recently until October 1, 2017.
United States
1 Sep 2017
Medicare Releases Drug, Device Open Payments Data
An article in Bloomberg BNA's Pharmaceutical Law & Industry Report and other publications, "Medicare Releases Drug, Device Open Payments Data," discussed the recent annual release...
United States
11 Jul 2017
FDA Postpones Deadline For Changes To Nutrition Facts Label
On June 13, the U.S. Food and Drug Administration (FDA) announced that it is postponing the compliance deadline for new rules for the Nutrition Facts Label, previously discussed here.
United States
28 Jun 2017
Drug, Device Makers Could Get Hit for Not Reporting Payments to Doctors
Day Pitney healthcare attorney Eric Fader was quoted in an April 12 article, "Drug, Device Makers Could Get Hit for Not Reporting Payments to Doctors," in Bloomberg BNA's Life Sciences Law & Industry Report and other publications.
United States
18 Apr 2017
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