FDA Law Blog: Biosimilars
APRIL 8, 2025
Leading FDAs policy implementation of the MODERN Labeling Act , the statutory authority allowing FDA to make certain generic drug labeling updates. Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA. But thats all in the past now.
Express Pharma
DECEMBER 30, 2024
In the case of both, PAN-40 and Augmentin 625 Duo, the statement divulges, The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subject to the outcome of the investigation.
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Express Pharma
FEBRUARY 12, 2025
billion in 2024 and projected to reach $11.55 On one hand, the Indian government has taken proactive steps to explore bringing nutra products under the purview of the Central Drugs Standard Control Organisation (CDSCO) by setting up a government-constituted panel in February 2024. billion by 2030, according to a GlobeNewsWire report.
FDA Law Blog: Biosimilars
JUNE 2, 2025
RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Indeed, FDA states, the existence of a certification program alone would not relieve manufacturers from their responsibilities to ensure that their labeling and distribution practices for RUO/IUO products are consistent with the products RUO/IUO label.
Express Pharma
MARCH 20, 2025
Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Accessed February 20, 2024. 2021;398(10300):583-598. 2022;327(6):534-545. doi:10.1001/jama.2022.0078 Hypertension.
Drug Channels
DECEMBER 9, 2024
During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. Below, we review the 20 products competing with Humiraincluding four private-label products marketed by in-house subsidiaries owned by CVS Health and Cigna. Click here to see the original post. All rights reserved.
Express Pharma
NOVEMBER 7, 2024
On 7 November 2024, the U.S. Since many products may be sold under the same brand name, the FDA advises consumers to check the Drug Facts label on medications to confirm the active ingredients and to heed any associated warnings and directions. She advised consumers to consult healthcare professionals for further guidance.
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