News & Events
RAPS: FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar […]
GMP: EMA issues new Guideline on “Chemistry of Active Substances”
A medicinal product authorization application requires comprehensive information on origin and quality of an active substance. What information is required was defined in two Guidelines so far: the Guideline “Chemistry of Active Substances” (3AQ5a) from 1987 and the “Guideline on the Chemistry of New Active Substances” from 2004. http://www.gmp-compliance.org/enews_05704_EMA-issues-new-Guideline-on-%22Chemistry-of-Active-Substances%22.html
FDA: Considerations in Demonstrating Interchangeability With a Reference Product
This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
RAPS: CDRH Warns Three Foreign Medical Device Manufacturers
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea. The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device […]
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of January 03, 2017 on guidelines for the naming of medicinal products for human use. http://www.urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-rejestracji-produkt%C3%B3w-leczniczych-wyrob%C3%B3w-medycznych-i-produkt%C3%B3w-8
EMA: Promoting high-quality clinical research in children through strengthened international collaboration
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its ninth annual workshop on 16 May 2017 in London, UK. The aim of the workshop, that will take place at the premises of the European Medicines Agency (EMA), is to bring relevant stakeholders together to discuss requirements, barriers and opportunities […]
RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance
Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. https://www.raps.org/News-and-Articles/News-Articles/2022/10/FDA-finalizes-multiple-endpoints-guidance
RAPS: UK on Brexit Implications: “Significant Benefits” to Remain Part of EMA
The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).
EMA: Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease
The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease’, in order to take into account issues identified since the guideline came into effect and experience gained […]