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Bayer Recalls BronkAid Due to Missing Labeling

[ Price : $8.95]

Bayer HealthCare recalls its BronkAid Caplets Dual Action Formula product after discovering that certain Drug Facts information wa...

FDA Approves Ethicons Fibrin Sealant Patch

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FDA approves Ethicon Biosurgerys Evarrest Fibrin Sealant Patch, intended for use as an aid in stopping problematic bleeding during...

CDER Antipsychotic Guru Laughren Retires

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CDER Division of Psychiatry Products director Thomas Laughren retires after nearly 39 years working in the federal government, the...

Healthpoint, DFB Pharma Fined $48 Million in False Claims Settlement

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Healthpoint Ltd. and DFB Pharmaceuticals agree to pay up to $48 million to resolve allegations that Healthpoint caused false claim...

Committee Probes Compounding Associations Role in FDA Sample Requests

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House Energy and Commerce Committee leaders ask the International Academy of Compounding Pharmacists for documents that may shed l...

Qualitest Recalls Hydrocodone/Acetaminophen Tablets

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Qualitest recalls 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10mg/500mg.

Janssen Bio Files sBLA for Stelara in Psoriatic Arthritis

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Janssen Biotech submits a supplemental BLA seeking approval for Stelara in treating adult patients with active psoriatic arthritis...

Bill on Compounding Oversight Introduced

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Reps. DeLauro and Lowey introduce legislation to strengthen regulation of compounding pharmacies.

CDRH Mobile Apps Final Guidance Close

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CDRHs final guidance is close to being published, Center policy advisor Bakul Patel tells an industry meeting during a broad-rangi...

Criticism of FDA Can Lead to Lack of Innovation: Woodcock

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CDER director Janet Woodcock says external pressures on FDA can lead to a feeling among staff that they should pursue traditional ...