Policy & Regulation

Senator Targets Amgen and Indivior Acquisitions for Antitrust Action

by Hayden Schmidt

Last week, the Senator from Massachusetts, Elizabeth Warren, penned a letter to the Federal Trade Commission (FTC) where she characterized recent consolidation in the pharmaceutical industry as a...

FDA Issues Draft Guidance Regarding Lead Levels in Processed Baby Food

by Veronica Salib

On January 24, 2024, the FDA issued a new draft guidance regarding lead levels in processed baby food meant for children under two as part of its Closer to Zero initiative. The Closer to Zero...

FDA Issues Draft Recommendation for Updated Blood Donation Guidelines

by Veronica Salib

On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to...

The Fundamentals of Animal Testing in Clinical Research

by Alivia Kaylor

While several different approaches are used during clinical research, traditional biomedical research involving animal testing to develop new treatments and drugs may be a strategy of the past after the FDA Modernization Act 2.0 was signed...

FDA Approves New Adjunctive Treatment for Depression

by Veronica Salib

Major depressive disorder (MDD) — commonly referred to as depression — affects approximately 20% of adults in the United States. MDD symptoms may include depressed mood, appetite changes,...

How to Improve Regulatory Measures for Dietary Supplements

by Veronica Salib

Across every pharmacy, grocery store, and convenience store in the United States, dietary supplements — in some shape or form — line the shelves. Many patients have the misconception that because these products are sold and...

Reimagining the Global Pharmaceutical Supply Chain

by Veronica Salib

Workforce optimization, compliance challenges, and supply chain disruptions are all issues that plague the global pharmaceutical supply chain — an essential part of the healthcare system. Because global pharmaceutical supply chain...

COVID-19 Vaccination Alters Menstrual Cycle Length

by Veronica Salib

As the COVID-19 pandemic continues and vaccinations continue to be advanced, many patients are concerned about vaccine side effects. Multiple sources have perpetuated the misconception that COVID-19...

President Biden Calls for Reform on Marijuana Regulation

by Veronica Salib

For many minority communities, marijuana possession and use can lead to years of incarceration for nonviolent offenses. The Biden administration has recognized that the harsh punishment around...

How Federal and State Laws Have Hindered Access to OUD Treatment

by Veronica Salib

The opioid epidemic has persisted over the past few decades. Exacerbated by the pharmaceutical industry, this epidemic has left many struggling with opioid use disorder (OUD). Effective treatments for...

Medications in the US Are More Widely Available than in Germany

by Veronica Salib

A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...

Federal Judge Rules against Mandated HIV PrEP Coverage

by Veronica Salib

In a recent court ruling, United States District Judge Reed O’Connor declared that mandated HIV PrEP coverage impedes religious freedom. This ruling provides a precedent for employers to refuse...

HRA Pharma Submits FDA Application for First OTC Birth Control Pill

by Veronica Salib

HRA Pharma has submitted an FDA application to allow the OTC sale of their progestin-only daily birth control pill, Opill. If this application is approved, this will be the first birth control pill...