Searching Content indexed under Food and Drugs Law by Day Pitney LLP ordered by Published Date Descending.
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Enhanced Medicaid Drug Review Requirements
On August 5, the Centers for Medicare & Medicaid Services (CMS) released new guidance for states and Medicaid managed care programs to update their two-phase Medicaid drug utilization review programs to screen drug...
United States
8 Aug 2019
HHS And FDA Release Drug Importation Action Plan
On July 31, 2019, the U.S. Department of Health and Human Services, in conjunction with the Food and Drug Administration, released an action plan for the importation of certain drugs originally intended for foreign markets, ...
United States
2 Aug 2019
Marijuana Update: Must New Jersey Employers Accommodate Medical Use?
New Jersey's Compassionate Use of Medical Marijuana Act does not require employers to accommodate employees' medical marijuana use in the workplace.
United States
10 Jul 2019
New FDA Guidance On Review Of Drug Promotional Materials
On June 21, the US Food and Drug Administration (FDA) finalized industry guidance pertaining to the requirements and recommendations for manufacturers
United States
9 Jul 2019
White Collar Roundup - June 2019
Earlier this month, U.S. District Judge Edgardo Ramos of the Southern District of New York sentenced a former assistant basketball coach for the University of Arizona to three months in prison.
United States
3 Jul 2019
CMS Provides More Flexibility For Medicare Part D Plans On Prior Authorization And Step Therapy For Certain Drugs
The Centers for Medicare & Medicaid Services (CMS) published a final rule on Thursday, May 16, 2019 that provides, among other things
United States
6 Jun 2019
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
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