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Comment Period Regulatory Oversight Prescription Drugs

Morgan Lewis - As Prescribed

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

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The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

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On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

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FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

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On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

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CMS proposes requiring drug prices in TV ads

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On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Akerman LLP - Health Law Rx

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Hogan Lovells

Administration presents plans to lower drug prices

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On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

Robinson+Cole Health Law Diagnosis

CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D...more

Hogan Lovells

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

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The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in...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

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