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Opioid Makers Must Provide Mail-back Envelope

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FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and...

Untitled Letter to Minneapolis Regenerative Medicine

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CBERs Office of Compliance and Biologics Quality sends an untitled letter to Minneapolis Regenerative Medicine over claims made on...

De Novo Granted to Sleeping Infant Device

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FDA grants a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on...

Guide on Dog Infectious Otitis Externa Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Infectious Otitis Externa Drugs for Topical Use in Dogs.

Deficiencies Found in Ascendis Pharma NDA: FDA

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FDA finds deficiencies in Ascendis Pharmas NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism.

Draft Guide on AI Device Software Changes

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Federal Register notice: FDA makes available a draft guidance entitled Marketing Submission Recommendations for a Predetermined Ch...

54% of Confirmatory Studies Are Late Meeting Deadlines

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A JAMA research letter says 54% of accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in ...

Accelerated Approval Given to Astellas Padcev

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FDA approves an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Mercks Keytruda in certain patients with loc...

FDA Hits India Drug Maker with 14-page 483

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FDA issues a 14-page Form FDA-483 to Global Pharma Healthcare in Tamilnadu, India that cites significant GMP deficiencies with its...

Bill Would Prevent ANDA Blocking on 1st Generics

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Senators Tina Smith (D-MN) and Mike Braun (R-IN) reintroduce bipartisan legislation that would prevent brand drug companies from s...