FDA

FDA Announce Additional Frozen Fruit Recall: Hepatitis A Contamination

by Veronica Salib

Last week, the FDA issued an announcement recalling multiple kinds of frozen fruit by Willamette Valley Fruit Co. The company is recalling the Great Value sliced strawberries, mixed fruit, and...

FDA Provides Guidance for Preventing Contamination in Tattoo Ink

by Veronica Salib

On June 12, 2023, United States Food and Drug Administration officials provided guidance for reducing microbial contamination in tattoo ink. The draft recommendation, now open for public commentary,...

Government Health Leaders Request Additional Data on Drug Test Strips

by Veronica Salib

Although drug-checking tools such as fentanyl test strips have been championed as critical harm-reduction tools in the opioid epidemic, additional data and research are required to assess their...

Top Challenges Facing Biosimilar Adoption and Manufacturing

by Veronica Salib

Biosimilar adoption by the healthcare industry can incentivize pharmaceutical development and increase options for patients, payers, and providers by offering a less expensive alternative to biologic...

How Inflation, Competition, Biosimilars Affect Prescription Drug Costs

by Editorial Staff

As the inflation rate continues to rise, the healthcare industry — like every other industry — is taxed with extraordinarily high costs. Rising drug prices have caused increased healthcare expenditures and out-of-pocket costs....

FDA Turns to China for Chemotherapy Drug Imports Amidst Shortage

by Veronica Salib

In a statement issued on May 24, 2023, Qilu Pharmaceutical Co, a Chinese pharmaceutical company, will export cisplatin, a chemotherapy drug, to the United States. Amidst shortages that began in early...

Examining Challenges and the Potential of Integrating AI in Healthcare

by Alivia Kaylor

As the healthcare industry continues to embrace artificial intelligence (AI), experts are examining the challenges that hamstring the adoption of this transformative technology.   Understanding the challenges and potential of...

FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines

by Veronica Salib

On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current...

FDA Issues Warning on Compounded Semaglutide Products

by Veronica Salib

Compounded forms of semaglutide have been linked to adverse events, leading to FDA-issued warnings. As a result, the FDA recommends that patients avoid compounded semaglutide whenever the approved...

Researchers Explore Ozempic as a Potential Addiction Treatment

by Veronica Salib

Gaining popularity from celebrity endorsements and public speculation, Ozempic has become a staple weight loss drug in the United States. However, researchers speculate that the medication could...

FDA Approves New Opioid Reversal Nasal Spray, A Harm Reduction Tool

by Veronica Salib

On May 22, 2023, the FDA approved Opvee, a nalmefene hydrochloride nasal spray that can reverse an opioid overdose in patients 12 and older. This approval adds a harm-reduction tool to existing tools,...

CDC Update Identifies Fourth Death Linked to Eyedrop Recall

by Veronica Salib

On May 19, 2023, the CDC released an update on the Pseudomonas aeruginosa outbreak linked to artificial tears from Global Pharma Healthcare. The report identifies a fourth death linked to the series of...

FDA Advisory Committee Favors Approval of Intranasal Epinephrine

by Veronica Salib

On May 11, 2023, the United States FDA Pulmonary–Allergy Drug Advisory Committee (PADAC) favored the approval of Neffy, the first intranasal epinephrine spray for allergic reactions. The panel...

FDA Finalizes Blood Donation Guidelines, Expands Eligibility

by Veronica Salib

After months of deliberation and review, the FDA has finally expanded its blood donor eligibility by adjusting its donation guidelines. Joining other developed nations, including the United Kingdom and...

Syphilis Rates Continue to Rise as Penicillin Availability Falls

by Veronica Salib

In April, the United States Food and Drug Administration (USFDA) announced a shortage of injectable penicillin, penicillin G benzathine, adding to the never-ending list of medications with supply chain...

A Melatonin Study Highlights a Lack of Supplement Regulation

by Veronica Salib

JAMA recently published a research letter highlighting the lack of supplement regulation by comparing the amount of melatonin and CBD in varying brands of melatonin gummies. The researchers determined...

FDA Publishes Draft Guidance for Decentralized Clinical Trials

by Veronica Salib

Yesterday, the FDA published a copy of its draft guidance for decentralized clinical trials, adding to previously issued guidelines. Clinical trial participants may be able to bring trials to their...

US Continues to Increase Its Reliance on Chinese Pharma Supply Chain

by Hayden Schmidt

According to research from the Atlantic Council, pharmaceutical products have become a valuable part of the United States and China’s trading relationship, growing from 0.6% of the total trade to...

FDA-Approved Cell Therapy Protects Patients After Stem Cell Transplant

by Veronica Salib

The FDA recently approved Omisirge (omidubicel-onlv), a new cell therapy meant to protect patients with blood cancer after a stem cell transplant. According to the press release, the treatment can...

FDA Updates EUA for Bivalent mRNA COVID-19 Vaccines to Simplify Use

by Veronica Salib

On April 18, 2023, the FDA issued an announcement, updating the emergency use authorization (EUA) for the bivalent mRNA COVID-19 vaccines. Attempting to simplify use for healthcare professionals, the...