FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Medical Devices

Panel to Discuss Non-invasive Ocular Pump

FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lower intraocular pres...

latest-news-card-1
Human Drugs

Key Patient Long Covid Meeting Themes

FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.

latest-news-card-1
Marketing

Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and conflate product benefits and risks when exposed t...

latest-news-card-1

Digital Health Research Grants Available

FDA solicits applications for grants to explore the role of digital health technologies in evaluating new drugs.

latest-news-card-1
Human Drugs

FDA to Make Compounding Difficulty Lists

FDA proposes to evaluate drugs and categories of drugs that present demonstrable difficulties for compounding and place three categories on the lists.

latest-news-card-1
Human Drugs

Bipartisan Bill to Shore Up Emergency APIs

Two U.S. House lawmakers introduce a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential gener...

latest-news-card-1
Federal Register

FDA Withdraws NDA/NADA for Helium

Federal Register notice: FDA withdraws approval of an Air Products and Chemicals NDA and new animal drug application for medical gas helium because th...

Human Drugs

Renal PK Study Guidance

FDA publishes a guidance to assist in the design and analysis of studies assessing the influence of impaired renal function on an investigational drug...

latest-news-card-1
Human Drugs

Iclusig Accelerated Approval for Leukemia

FDA grants Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with newly diagnosed Philade...

latest-news-card-1
Human Drugs

FDA Accepts BLA Resubmission for Lymphir

FDA accepts for review a Citius Pharmaceuticals BLA resubmission for Lymphir (denileukin diftitox), an interleukin-2-based immunotherapy for treating ...