Regulatory Updates – March 19

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US FDA: Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry

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US FDA: Product-Specific Guidance’s for Generic Drug Development

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UK Seeks to Increase Clinical Trials Transparency

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TGA Seeks Feedback on Criteria to Support Drug Down-Scheduling 

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Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations -Draft Guidance

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Bioavailability Studies Submitted in NDAs or INDs — General Considerations – Draft Guidance

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FDA Defends its Efforts to Ensure Generic Drug Quality

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Govt amends D&C Rules to regulate brand names; cos needs to furnish undertaking to avoid confusion over LASA drugs

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TN DCA to introduce digital services for accepting applications & issuing licenses for pharma manufacturers

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Cosmetics licences may come with product composition details to enhance safety; new clause proposed in Cosmetics Rules 2018

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Govt brings 42 non-scheduled cancer drugs under price control, trade margin capped at 30 per cent

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Procedural update on submission of Type I variations to EMA in March, April and May 2019

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EMA Kicks Off Series of EU MDR/IVDR Guidance

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US FDA: Office of Pharmaceutical Quality – 2018 Annual report

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DCGI enlists procedures for regularisation of 83 FDCs, issues 7 pointers to be adhered for approval submission before June

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India’s bid to bring OTC drug regulations gains momentum; 3-member panel in place to examine expert recommendations

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Change of time zone due to EMA’s relocation in March 2019

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HPRA- Guide to Reclassification (Switching) of Legal Supply Status for Human Medicinal Products

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TGA Proposes 5 Medical Device Classifications in Line with EU MDR

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CDRH Classifies Software App for Contraception into Class II

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CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews

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CDER Guidance Agenda for 2019: What’s Coming

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MHRA Sets No-Deal Brexit Process for Pharma Submissions

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New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall

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EMA- Regulatory information – adjusted fees for applications to EMA from 1 April 2019

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Transition to ISO 13485:2016 Comes to an End

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FDA Finalizes Guidance on 503B Bulks List

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CDSCO comes out with clarification about issuance of NOC for Form 29 license

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