The FDA Law Blog

APRIL 8, 2025

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

FDA

Drug Topics

JULY 8, 2025

Recent Videos Related Content Flip The Pharmacy April Schedule & Sign-Up March 28th 2024 Article Check out these can't-miss Workflow Wednesdays sessions in April. Flip The Pharmacy March Schedule & Sign-Ups March 4th 2024 Article Check out these can't-miss Workflow Wednesdays sessions in March.

Health and Personal Care Stores

Drug Topics

JULY 25, 2025

The 2024 National Pharmacist Workforce Study reveals a profession under pressure. Final Report of The 2024 National Pharmacist Workforce Survey. Pharmacy Workforce Center; Washington, DC, USA: 2024. 1 Pharmacists report increasing dissatisfaction tied to workplace stress, corporatization, and a lack of flexibility. References 1.

Specialty Pharmacies

Drug Topics

JUNE 18, 2025

March 21, 2024. KFF Health Tracking Poll May 2024: The Public’s Use and Views of GLP-1 Drugs. May 10, 2024. As obesity rates rise in the U.S. and worldwide, new weight-loss drugs surge in popularity. Pew Research Center. June 18, 2025. Montero A, Sparks G, Persiado M, Hamel L. June 18, 2025.

Compounding

Drug Topics

JUNE 6, 2025

Updated October 11, 2024. Updated October 11, 2024. Updated July 15, 2024. May 15, 2024. The Immunization Action Coalition. Travel Vaccines. Accessed May 16, 2025. Travelers’ Health. Accessed May 16, 2025. Plan for Travel. Accessed May 16, 2025. Yellow Fever Vaccine. Accessed May 16, 2025.

Vaccines

The FDA Law Blog

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

FDA

Drug Topics

JULY 9, 2025

But in 2024, that number fell to just 2.8%.” Specifically focused on coping mechanisms, work environment, pharmacist advice to students, and their influence on student career paths, researchers distributed a 22-question survey to pharmacy students in Pennsylvania during the spring 2024 semester. December 3, 2024. June 16, 2025.

Health and Personal Care Stores

STAT

JANUARY 6, 2025

In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has received over 500 drug submissions with AI components since 2016, with a large number in the areas of oncology, neurology, and gastroenterology.  

FDA

Drug Topics

AUGUST 8, 2025

12,13 The American Medical Association surveyed physicians on AI utilization and found that by 2024, nearly two-thirds of physicians had used at least 1 AI tool. March 21, 2024. The top 15 specialty pharmacies of 2024: how PBMs, health systems, and independents are shaping the market. December 16, 2024. News release.

Specialty Pharmacies

European Pharmaceutical Review

APRIL 21, 2025

For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Why is the FDA’s decision to approve Dupixent as a new treatment for chronic spontaneous urticaria significant?

FDA

Drug Topics

AUGUST 4, 2025

October 25, 2024. More US pharmacies closed than opened in 2018–21; independent pharmacies, those in Black, Latinx communities most at risk. Health Affairs. 2024;43(12):1703-1711. Struggles at CVS, Rite Aid, and Walgreens call into question retail pharmacy’s future. Murphy M, Rodis J. The growing crisis of pharmacy deserts. April 28, 2025.

Community Pharmacies

Drug Topics

JUNE 6, 2025

December 18, 2024. link] Recent Videos Related Content FDA Grants Expanded Interchangeability Designation to Yuflyma Ashley Gallagher May 23rd 2025 Article Adalimumab-aaty (Yuflyma) prefilled syringes and autoinjectors are now fully interchangeable with the reference product adalimumab (Humira) across marketed dosage forms and strengths.

FDA

Drug Topics

JULY 10, 2025

PwC’s 2024 Voice of the Customer report found that 80% of consumers are willing to pay more for sustainably produced or sourced goods, despite overall rising costs. sustainability premium, even as cost-of-living and inflationary concerns weigh: PwC 2024 Voice of the Consumer Survey. April 2025. Consumers willing to pay 9.7%

Health and Personal Care Stores

Drug Topics

JULY 21, 2025

In August 2024, the American Medical Association (AMA), the advocacy group for US physicians, wrote a letter to US Congress opposing legislation that would allow pharmacists to test and treat patients with specific illnesses. 2024 Sep 24;46:101088. August 9, 2024. Muscat NA, Sinclair P, Zapata T, et al. Lancet Reg Health Eur.

Specialty Pharmacies

Drug Topics

JUNE 20, 2025

Pneumococcal Burden Remains Despite Immunization Expansion Ashley Gallagher June 9th 2025 Article The Advisory Committee on Immunization Practices voted to lower the pneumococcal recommendation to 50 years in October 2024. Passport to Protection: Best Practices for Travel Vaccines in the Pharmacy Setting Gretchen K.

Vaccines

The FDA Law Blog

JULY 8, 2025

Snow — Recently, FDA announced a deadline shift, although the Agency did so quietly. Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer. By Charles D. What does this mean?

FDA

Drug Topics

JUNE 30, 2025

In the cross-sectional study, investigators used data from the 2018 to 2024 Mental Health and Addiction Treatment Tracking Repository. However, data on low-dose initiation compared with traditional initiation is still limited.

Compounding

STAT

NOVEMBER 8, 2024

However, the FDA action is only related to orally administered phenylephrine and not the nasal spray form. Last year, an FDA advisory panel unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.

FDA

Drug Topics

JULY 2, 2025

3,4 Since then, several other formulations have received FDA approval, leading to research developments of multiple GLP-1s for treating people with overweight or obesity. April 4, 2024. Innovators who fought to unlock GLP-1 drugs for obesity awarded Mani L. Bhaumik Breakthrough of the Year Award. Accessed July 1, 2025.

Compounding

Drug Topics

AUGUST 12, 2025

Data for the prospective multisite survey study was gathered from 2 chain grocery stores in Maryland between December 2023 and March 2024. For the study, a survey was given to eligible patients who came to the pharmacy.

Vaccines

PharmaVoice

JULY 1, 2025

To help close that gap, patients stood up to tell their own stories during open, public portions of an FDA advisory committee meeting for the approval of one of Ardelyx’s drugs. That stole the day because they told us and the FDA why there was a need in this space,” she said. “In

FDA

The FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

FDA

Drug Topics

JULY 14, 2025

Dynamics that have become apparent during 2024 have driven significant revisions to the outlook, and in this report, the drivers of change in medicine spending over the next 5 years are deconstructed to enable better understanding,” wrote IQVIA. There [were] up to 48 novel drugs launched in the US in 2024; 31 of them were orphan drugs.

Immunization

IDStewardship

JANUARY 13, 2025

BCIDP UNDER CONSTRUCTION Article PostedXXX Sulopenem etzadroxil and probenecid (Orlynvah) was recently approved in October 2024 for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis. 2024 Nov 2:S1198-743X(24)00507- X. Hosp Pharm. Dunne MW, et al.

Packaging

PharmaVoice

JULY 21, 2025

Editors pick Stock via Getty Images Why FDA’s CRL release could open the door to lawsuits against pharma In a push for “radical transparency” the FDA released 200 CRLs for drugs that were later approved — some of which are now public for the first time. Please select at least one newsletter.

FDA

Pharmacy Times

AUGUST 1, 2025

The approval builds upon concizumab’s previous December 2024 clearance and allows for treatment in patients with hemophilia A or B, both with or without inhibitors.

FDA

Pharmacy Times

AUGUST 12, 2025

Published May 6, 2024. Published March 22, 2024. FDA Approves V116 for Prevention of Invasive Pneumococcal Disease and Pneumonia. Published June 18, 2024. Last Updated October 2, 2024. Published October 21, 2024. Accessed August 11, 2025. Gallagher A. Pharmacy Times. Accessed August 11, 2025. Gallagher A.

Immunization

Drug Topics

JUNE 18, 2025

Published 2024 Nov 25. Eggers S, Hoggarth ZE, Nagdeo K, et al. Food Insecurity Modifies the Association Between the Gut Microbiome and the Risk of Cognitive Impairment in Adults. rs-5486286. doi:10.21203/rs.3.rs-5486286/v1 rs-5486286/v1 3. Nowosielski B, Gupta V. Why Digital Innovation Will Transform the Future of Smart Pharmacy | NCPDP 2025.

Communication

Pharmacy Times

AUGUST 6, 2025

According to the CDC, national kindergarten vaccination coverage dropped to 93% in the 2023-2024 school year, down from prepandemic levels of approximately 95%. October 2, 2024. August 2, 2024. Vaccine coverage and exemptions among kindergarteners. Accessed July 16, 2025. McKee C, Bohannon K. J Pediatr Pharmacol Ther.2016;21(2):104-109.

Vaccines

Drug Topics

JULY 2, 2025

2024 Nov 15:dgae778. Tillman JB, Beck RW, Polonsky WH, et al. Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A Six-Month Analysis. J Clin Endocrinol Metab. doi: 10.1210/clinem/dgae778. Epub ahead of print. PMID: 39546625.

Patient Care

European Pharmaceutical Review

MAY 5, 2025

Building on clinical evidence for Tremfya in ulcerative colitis and Crohn’s disease This new data adds to earlier clinical result s released in May 2024 from a maintenance study of Tremfya in ulcerative colitis. In September 2024, the US FDA granted approval for intravenous administration of the drug in adults with ulcerative colitis.

FDA

The Checkup by Singlecare

DECEMBER 26, 2024

2024 has been a busy year for new drugs. Over 40 new medications have been approved by the FDA, giving patients more options for treating various health problems. Zelsuvmi (berdazimer) Zelsuvmi received the green light from the FDA on January 5, 2024. Xolremdi (mavorixafor) The FDA approved Xolremdi on April 26, 2024.

FDA

Pharmaceutical Technology

JUNE 25, 2025

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.

FDA

PharmaVoice

JULY 31, 2025

Jazz sings new tune with CEO switch Jazz Pharmaceuticals made history by scoring the first FDA approval for a CBD-based drug in 2018. News of the shift has fueled investor speculation that Kenvue is preparing to sell some of its brands or setting the stage for an outright acquisition of the company, which is currently valued at $40 billion.

FDA

PharmaVoice

JUNE 6, 2025

The first one approved by the FDA — Mylotarg from Pfizer subsidiary Wyeth for acute leukemia — came to market in 2000. Now, 15 different molecules have been approved by the FDA. It wasn’t always a sure bet that ADCs would break through the noise, though.

Chemotherapy

European Pharmaceutical Review

AUGUST 8, 2025

Three of the planned new US sites will focus on active pharmaceutical ingredients (APIs) , domestic production of which is an issue close to the heart of the FDA, while the fourth will expand Lilly’s global parenteral manufacturing network for future injectable therapies.

Medical Schools

Pharmaceutical Technology

AUGUST 11, 2025

Buy Reports Newsletters PT News FDA gives Arvinas and Pfizer’s vepdegestrant NDA for breast cancer Vepdegestrant is an investigational, oral bioavailable PROteolysis TArgeting Chimera (PROTAC) medication. Credit: Gorodenkoff/Shutterstock.com.

FDA