The US Food and Drug Administration (FDA) issued its final guidance in April on initiating voluntary recalls for drugs, biologics, and medical devices. Although largely in line with the previous draft guidance issued in April 2019, the agency made changes based on public comments. The non-binding […]
UCB’s Psoriasis Drug’s FDA Application on Pause Due to Facility Inspection Issues
The US Food and Drug Administration (FDA) has temporarily halted the approval process for UCB’s psoriasis drug bimekizumab on concerns with facility inspections. This is the second delay UCB has faced thus far related to inspections, with the agency postponing the company’s application last October […]
FDA Approves Eli Lilly Diabetes Drug
The US Food and Drug Administration (FDA) has given the green light to Eli Lilly’s new type II diabetes therapy Mounjaro. The injectable drug is hailed as a potential blockbuster for Lilly, which has seen its stocks jump by 50% in the past year. Clinical trial data showed that the drug reduced A1C […]
Cytel Announces Free Statistical Programming Ebook
When submitting data to the US Food and Drug Administration, maintaining a steady line of communications is essential. Frequent technical discussions can help ensure sufficiently thorough guidance from the agency and reduce snags in the process made by time-consuming corrections. In a […]
FDA Roundup – Week of May 10th
In the latest weekly FDA roundup, the agency has approved the immunomodulatory COVID-19 drug for use in hospitalized adult patients needing external oxygen. This adds to the drug’s current indications, which include use in hospitalized children with COVID-19. In other news, the agency just posted a […]
FDA Creates New Training Program for mRNA Vaccine Manufacturing Inspectors
As mRNA technology has been thrust into the mainstream with the advent of COVID-19 vaccines, the US Food and Drug Administration (FDA) has begun training new investigators to meet the increasing demand for mRNA vaccine manufacturing inspections. The trainees will undergo a mix of in-person, virtual […]
CDER Director Requests Accelerated Approval Reforms and Expresses Worries over Recent Court Decisions
Patrizia Cavazzoni aired her concerns about recent court cases and made requests regarding accelerated approval reform in a recent hearing before the US Senate Health, Education, Labor, and Pensions Committee. Cavazzoni, Director of the enter for Drug Evaluation and Research (CDER) at the FDA, […]
Webinar: Lessons Learned from Inspections and Audits During COVID-19
While the efforts and procedures of many regulatory bodies ground to a halt during the COVID-19 pandemic, the US Food and Drug Administration (FDA) pressed on with inspection. However, the agency’s tactics shifted as it adopted remote tools to connect with pharma and digital health companies before […]
Language in FDA Decisions Could Signal Increased Scrutiny in Approval Decision-making
The wording in the US Food and Drug Administration’s (FDA) recent decision not to approve Pfizer and Myovant’s endometriosis application may signal a tightening of the agency’s standards for regulatory approval. The key phrase drawing attention is, “deficiencies that preclude discussion of labeling […]
Fitbit Cleared by FDA for Afib Detection
The US Food and Drug Administration (FDA) has approved Fitbit’s algorithm for passive round the clock atrial fibrillation (afib) detection. The algorithm, validated in a 2020 study, uses photoplethysmography (PPG) sensor technology, much like the technology used by the Apple Watch, which was […]
