Policy & Regulation

FDA opens discussion on optimizing advisory committees to the public

May 2, 2024 - In June, the United States FDA will host a listening session on FDA advisory committees, encouraging public engagement as a part of broader efforts to optimize the use of and process for these committees, which play a critical role in reviewing FDA-approved products and providing recommendations. The meeting will be held virtually and will include...

Read More


More Articles

Exploring 5 types of intellectual property protections in pharma

by Veronica Salib

The Journal of Advanced Pharmaceutical Technology & Research defines intellectual property as “any original creation of the human intellect such as artistic, literary, technical, or scientific creation.” Intellectual...

EPA finalizes chemical plant clean air standards

by Veronica Salib

On April 9, 2024, the United States Environmental Protection Agency (EPA) finalized a ruling to regulate toxic air pollution from chemical plants. The finalized ruling focuses on two primary...

Rising adult melatonin use sparks concern over unsupervised child exposure

by Alivia Kaylor

In recent years, while melatonin use among adults in the United States has surged due to heightened awareness of sleep disorders and interest in natural remedies, a concerning trend has emerged:...

FDA issues warning letters for unapproved topical pain relief products

by Veronica Salib

On March 26, 2024, the United States FDA published a press release informing consumers of six warning letters sent to companies regarding unauthorized topical pain relief products. The following...

SCOTUS to issue a decision on mifepristone in the coming months

by Veronica Salib

The Supreme Court of the United States (SCOTUS) has yet to decide on mifepristone access in the US; however, many predict that the decision will come by late spring, June or July 2024 at the latest....

FDA ODAC favors 2 CAR T-cell therapies for multiple myeloma

by Veronica Salib

A meeting of the United States FDA Oncologic Drugs Advisory Committee (ODAC) voted to expand the approval of Abecma and Carvykti, two types of chimeric antigen receptor (CAR) T-cell therapies, for...

Exploring Transparency-Rx’s pharmacy benefit manager partners

by Veronica Salib

Transparency-Rx is a recently launched organization of transparent pharmacy benefit managers working towards addressing the ongoing challenges with pharmacy benefit managers (PBMs) that have hindered access to care and significantly...

FDA requests $7.2 billion from Biden’s 2025 fiscal year budget

by Veronica Salib

On March 11, 2024, the United States FDA issued a press release announcing its request for $7.2 billion from the president’s fiscal year (FY) 2025 budget, increasing its FY 2023 request by 7.4%...

Revolutionizing Vaccine Storage and Distribution with Innovative Solutions

by Alivia Kaylor

The global COVID-19 pandemic has highlighted the critical role of vaccines in controlling the spread of infectious diseases. As the demand for vaccines continues to rise, developing innovative solutions for their storage and distribution...

NIH Launches Cancer Screening Research Network for Early Detection

by Veronica Salib

On Wednesday, February 21, 2024, the NIH launched a clinical trial network for evaluating new cancer detection technologies or methods called the Cancer Screening Research Network (CSRN), which will...

Healthcare Workers Urge Health Systems to Address Climate Change

by Veronica Salib

Solidifying the connection between healthcare and climate change, a survey by the Commonwealth Fund revealed that nearly 80% of clinicians in the United States believe that their hospitals must address...

NY Charges Midwife $300K for Falsifying Vaccine Records

by Veronica Salib

Last week, the New York State Department of Health published a press release informing the public about charges against a Nassau County midwife who falsified vaccination records. "Misrepresenting or...

Evaluating the Series of Infant Formula Recalls in the US

by Veronica Salib

Infant formula plays a critical role in pediatric healthcare, providing an alternate route for nutrition in babies who do not breastfeed or may need more nutrients than what is provided in breast milk. Although many people, including...

Online Pharmacies Under Scrutiny for Lax Safety Checks, Endangering Patients

by Alivia Kaylor

In a groundbreaking investigation, the BBC uncovered a concerning trend in the online pharmaceutical industry, where prescription-only medicines are sold without adequate checks. The report exposes a...

FDA Approves First CRISPR-Based Gene Therapy

by Veronica Salib

Last week marked a monumental regulatory decision for CRISPR-based gene editing technologies. The United States Food and Drug Administration (FDA) approved the first two cell-based gene therapies for...

EPA Proposes Lead Pipe Removal to Minimize Human Exposure

by Veronica Salib

Under the guidance of the Biden–Harris administration, the Environmental Protection Agency (EPA) announced its plans to strengthen the Lead and Copper Rule as part of the Lead Pipe and Paint...

34% of Conventional Baby Food Contains Pesticides

by Veronica Salib

Earlier this month, the Environmental Working Group (EWG) published an updated version of their 1995 study on pesticides in baby food. Data revealed that while some threats have been eliminated, there...

FDA Publishes Drug Safety Communication for Antiseizure Drugs

by Veronica Salib

Earlier this week, the United States Food and Drug Administration (FDA) published a drug safety communication warning patients about potentially life-threatening side effects linked to levetiracetam...

Exploring Pharmacy Benefit Manager Reforms: Transparency

by Veronica Salib

Pharmacy benefit managers (PBMs) have received criticism over the past couple of years for pocketing savings intended for patients. While this rhetoric is true for some PBMs, a small subset of the market advocates for PBM transparency and...

Recent Articles