Unused medications pose a significant threat to healthcare, considering the impacts of improper disposal and drug misuse. Over-the-counter (OTC) and prescription medications that are expired or no longer needed by the intended patient...
On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...
The United States Food and Drug Administration (FDA) has been criticized repeatedly for shortcomings and flaws in its oversight protocols. Understanding the current regulations that the FDA follows for assessing drug manufacturing...
As a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), the FDA will now require mail-back envelops with opioid analgesic dispensation in outpatient settings to...
On March 24, 2023, the FDA issued a draft guidance on the clinical trial considerations for the accelerated approval of oncology drugs. The proposed recommendations include guidelines to fortify and...
On Friday, March 17, 2023, the FDA announced that Scenic Fruit Company has voluntarily recalled some of its frozen fruit sold at Aldi, Trader Joe’s, and Costco. This announcement was just one day...
In an annual report focused on the return on investment (ROI) from pharmaceutical innovation, Deloitte analyzed research and development (R&D) in the pharmaceutical industry and the resulting outcomes throughout 2022. Considering the...
On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should...
After speculation about acquisition deals earlier this month, Pfizer Inc has officially confirmed its acquisition of Seagen Inc. The $43 billion deal was a strategic move by Pfizer to expand the...
Medicine regulation, review, and authorization are critical tools for bringing drugs to market, monitoring patient safety, and ensuring the best health outcomes. While regulatory guidance can vary globally, comparing protocols can help...
Last week, the FDA added two more eye drops to its recall list: Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%) and Pharmedica USA LLC Purely Soothing 15% MSM Drops. These recalls follow a...
Pfizer Inc is reportedly in talks to buy the cancer drugmaker Seagen Inc after a potential acquisition by Merck last year fell through. In August 2022, it was reported that Merck was considering a $40...
Reckitt, a consumer goods company, recently issued a recall on two batches of its Enfamil 12.9 oz ProSobee Simply Plant-Based Infant Formula, amounting to more than 140,000 cans, due to potential...
On Tuesday, Pfizer announced that the FDA accepted for review its Biologics License Application (BLA) for the company’s respiratory syncytial virus (RSV) vaccine candidate RSVpreF. Depending on...
An investigation published in JAMA Internal Medicine assessed FDA-approved drugs and regulatory decisions made in other countries. In particular, the study focused on regulation and health technology...
Clinical trial significance and success throughout the COVID-19 pandemic have inspired the launch of clinical trial branches for existing companies, such as Walgreens, and multiple startups. However, it is critical to note that while some...
In House Bill 1047 — introduced on January 9, 2023, and sponsored by representative Sharlett Mena — Washington state has begun to take regulatory steps toward non-toxic cosmetics. The bill...
Global Pharma Healthcare has voluntarily recalled multiple batches of artificial tears after patients experienced severe side effects, such as vision loss and mortality. On January 31, 2023, the CDC...
The Orphan Drug Act of 1983 defines a rare disease as a medical condition that impacts less than 200,000 people in the United States. Despite the restrictive nature of this definition, the Genetic and Rare Diseases Information Center of...
Based on data and recommendations from an external review by the Reagan-Udall Foundation and the results of an internal study, FDA commissioner Robert M. Califf, MD, MACC, announced a new vision for...
