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Pharmaceutical Industry Fees

Foley Hoag LLP - Cannabis and the Law

Virginia Prepares to Accept Applications for a Single Medical Cannabis License for Health Service Area 1, Which Includes the...

Virginia’s HSA 1 Pharmaceutical Processor Permit - Effective January 1, 2024, the Virginia Cannabis Control Authority (CCA) assumed regulatory oversight of Virginia’s medical cannabis program. The CCA was established in...more

Smart & Biggar

Updates to Health Canada’s regulatory initiatives for 2022-2024, and amendments to Food and Drug Regulations (Exports and...

Smart & Biggar on

Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more

BakerHostetler

AD-ttorneys@law - May 2022

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NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more

Goodwin

FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2022

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Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug...more

Knobbe Martens

Is your funded medical device startup actually a “large entity” according to the USPTO?

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The U.S. Patent and Trademark Office (USPTO) allows a patent applicant to pay reduced fees if it qualifies as a “small entity.”  Many types of filing fees are reduced by 50%.  These savings can be important for companies on a...more

ArentFox Schiff

FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs

ArentFox Schiff on

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in...more

Womble Bond Dickinson

FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

Womble Bond Dickinson on

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

Sheppard Mullin Richter & Hampton LLP

FDA Announces Facility Fees for OTC Drug Manufacturers

On Friday, March 26, 2021, FDA published a Federal Register notice, “Fee rates under the Over-The-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing 2021 fee rates under its over-the-counter (OTC)...more

Arnall Golden Gregory LLP

OTC Monograph Fees Announced… Not So Fast!

On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter Monograph User Fee Act (OMUFA) Program for Fiscal Year 2021. Reed Tech...more

Wiley Rein LLP

OTC Drug User Facility Fees – Don’t Miss the Changes!

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On January 4, 2021, FDA unexpectedly withdrew the notice entitled Fee Rates Under the Over the Counter Monograph User Fee Program for Fiscal Year 2021 stating that it had been ordered to cease further collection efforts...more

Butler Snow LLP

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

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On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more

Holland & Knight LLP

OIG Warns Healthcare Providers on Speaker Fees Paid by Pharmaceutical, Medical Device Companies

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The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a Special Fraud Alert on Nov. 16, 2020, to highlight and warn healthcare professionals of inherent fraud and abuse risks associated...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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OxyContin maker Purdue Pharm is prepping for a possible bankruptcy filing “as it seeks to contain liability from hundreds of lawsuits alleging it fueled the nation’s opioid epidemic.” Officially, the company went on the...more

Hogan Lovells

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

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Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive...more

Goodwin

White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

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The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more

Robins Kaplan LLP

Your daily dose of financial news - The Brief – 9.19.16

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Gretchen Morgenson and Fair Game have had a few days to reflect on the Bayer/Monsanto deal, and with that little bit of hindsight (and a lot of history), she’s not too sure that Bayer’s stockholders are going to be thrilled...more

Shumaker, Loop & Kendrick, LLP

Client News Alert: Regarding Physician Payments Sunshine Act

On August 1, 2013 a new reporting obligation under the federal Physician Payments Sunshine Act (“Sunshine Act”) takes effect. The Sunshine Act was originally signed into law on March 23, 2010, as part of the Patient...more

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