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Continuous Manufacturing Part 3: Batch Size And Control Strategies
Deepak Hegde
May 18, 2021
This paper shows the definition of batch in continuous manufacturing, its importance from a regulatory perspective.
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MHRA joins international regulatory consortium
europeanpharmaceuticalreview
October 22, 2020
By joining the Access Consortium, the MHRA will work together with agencies from Australia, Canada, Singapore and Switzerland to expedite therapeutic product approvals.
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Industry positive about CDSCO’s move to digitalise regulatory approvals
expresspharma
October 22, 2020
Central Drugs Standard Control Organisation (CDSCO) plans to adopt a paperless office culture and is in the process of going completely digital for regulatory approvals. Recently, Dr S Eswara Reddy, Joint Drugs Controller, CDSCO had informed that ...
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FDA transitions to new regulatory pathway for biosimilars
europeanpharmaceuticalreview
March 25, 2020
The US FDA will now approve biosimilars via a new regulatory pathway to help grow the competition between biologic products.
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Strengthened regulatory systems are needed to improve drug safety, says report
europeanpharmaceuticalreview
January 17, 2020
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
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OssDsign AB (publ) Initiates Commercial Preparations for Launch in Japan Following Regulatory Filing for OssDsign Cranial
prnasia
August 12, 2019
OssDsign AB (publ) ("OssDsign" or the "Company"), the Swedish designer and manufacturer of innovative implants for bone regeneration, has filed for a Japanese regulatory approval of OssDsign Cranial.
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Sun Pharma announces regulatory filing of Tildrakizumab in Japan
biospectrumasia
August 01, 2019
Filing is a significant milestone in establishing the specialty business in Japan and adds one more potential market for Tildrakizumab globally
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First all-oral treatment for sleeping sickness leads positive recommendations from CHMP's November meeting
firstwordpharma
November 19, 2018
At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended four drugs for approval
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FDA panel slams Alkermes’ opioid-based depression drug
fiercebiotech
November 05, 2018
It has been a long and difficult road for Alkermes’ new depression drug, and Thursday’s advisory committee vote won’t make it any easier. The panel voted 21-2 against recommending...
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FDA staff spotlight big—but expected—issues on Alkermes' depression drug
fiercebiotech
November 02, 2018
The FDA raised significant—but expected—concerns about Alkermes’ major depressive disorder drug ALKS-5461 in briefing documents released (PDF) ahead of an advisory committee