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FDA Launches Crackdown on Deceptive Drug Advertising

On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The Agency announced it would:

Regulatory Sciences

Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...

Regulatory Sciences

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...

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Regulatory Sciences

Success in the European Pharmaceutical Market: Part Two

In part one, we covered the regulatory framework, compliance, and Wholesale Distribution Authorization. In part two, we’ll explore how success in Europe goes beyond regulatory approval—it’s also...

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Pharmacovigilance

The Role of the Local Person Responsible for Pharmacovigilance (LPPV) in the DACHL Region

Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their...

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Regulatory Sciences

Success in the European Pharmaceutical Market: Part One

According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world. Therefore, it is not surprising that many biotech...

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Regulatory Sciences

Key Steps to Creating a Successful Market Access Strategy

Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...

Quality & Compliance

Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...

Quality & Compliance

Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes

The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...

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Regulatory Sciences

Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers

On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...

Quality & Compliance

Navigating the Transition from ICH E6 (R2) to (R3)

Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the...

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Medical Information

Medical Information in the UK: Ensuring Compliance, Patient Safety, and Trust

In the highly regulated world of pharmaceuticals, medical information (MI) services play a critical role in ensuring that healthcare professionals, patients, and the public have access to accurate...

Regulatory Sciences

Scientific Data Works: Using Science to Navigate the Global Regulatory Maze

You’re developing an FDA – and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most...

Regulatory Sciences

FAQs: Model Informed Drug Development (MIDD) & Modeling and Simulation (M&S)

Question & Answer with Sander Vinks, PhD, PharmD, FCP, Regarding MIDD and M&S In the ever-evolving landscape of drug development, efficiency, precision, and regulatory success are paramount....

European Union Flags Flying In Front Of Building in Brussels

Regulatory Sciences

Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?

The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...

healthcare-professional-on-tablet

Medical Information

German Pharmaceutical Compliance: The Critical Role of Medical Information Teams

When a pharmaceutical company completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization. However, one...

What to Expect During the NDA Review Process

Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...

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FDA's Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

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What are Patient Support Programs?

Patient Support Programs (PSPs)  in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...

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Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or...

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Formal FDA Meetings for Sponsors or Applications of PDUFA Products

This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...

The QPPV: An Essential Guide to the Qualified Person Responsible for Pharmacovigilance

When submitting marketing authorisation applications (MAAs) in Europe, the applicant (Marketing Authorization Holder, MAH) shall already have set up a pharmacovigilance system. A Summary of the...