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FDA General

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company Tenderneeds Fertility.

Medical Devices

Nonbinding Feedback Guidance

FDA publishes a final guidance with a standardized method for device establishments to communicate and submit nonbinding requests for feedback on thei...

FDA General

Kessler Calls for New Social Contract on Covid-19

Likening Covid-19s threat to civilization to World War II, former FDA commissioner David A. Kessler calls for a new social contract that reduces our u...

Human Drugs

Guide on Temporary Pharmacy Compounding

FDA posts a guidance on a temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsou...

Federal Register

Device User Fee Meeting Postponed

Federal Register notice: FDA postpones until further notice a 5/5-scheduled public meeting entitled Medical Device User Fee Amendments for Fiscal Year...

Medical Devices

EUA Templates to Speed Serology Tests: FDA

FDA says it is working on emergency use authorization templates that laboratories and commercial manufacturers may use to facilitate the preparation a...

Human Drugs

Avet Pharma Recalls Tetracycline HCl Capsules

Avet Pharmaceuticals recalls several lots of tetracycline HCl capsules, 250 mg and 500 mg, 100-count bottles due to low out-of-specification dissoluti...

Human Drugs

Nova Botanix Warning on Unapproved Virus Products

FDA warns Nova Botanix that its CBD products are being marketed for unapproved drug uses in treating or preventing Covid-19.

Human Drugs

FDA Approves Pemazyre for Cholangiocarcinoma

FDA approves an Incyte Corp. NDA for Pemazyre (pemigatinib) for treating adults with certain types of previously treated, advanced cholangiocarcinoma,...

Human Drugs

Fresenius Kabi Recalls Ketorolac Tromethamine

Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection, 30 mg/ml, and ketorolac tromethamine injection 60 mg/2 ml due to the presence of p...