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Federal Register

Criteria on Difficult Compounding Lists

Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties f...

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Human Drugs

J&Js Edurant PED Approved for Pediatric HIV-1

FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in treatment-nave chil...

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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...

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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.

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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...