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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...

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Digital Health Research Grants Available

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

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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.

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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...

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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...

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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...

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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 ...

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Human Drugs

Senators Want Defense Drug Supply Security Update

A bipartisan group of nine senators asks the Defense Department for an update on its efforts to secure the military pharmaceutical supply chain.

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Human Drugs

Changes Proposed to Manufacturing Tech Draft

Two stakeholders make suggestions to revise an FDA draft guidance on its new drug advanced manufacturing technology designation program.