The U.S. Food and Drug Administration issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers – Guidance for Industry. The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease as one that is a …
Guidance Documents 7/26/2019 – Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry 7/23/2019 – Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industry 7/22/2019 – Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff CDRH Update Weight-Loss and Weight-Management Devices (Updated)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a 12-week consultation on how to best engage and involve patients in the Agency’s work. The responses will help inform the MHRA’s future engagement with patients and the public. The MHRA wants to adopt a more systematic approach to listening to and involving patients. They want to make sure …
ccording to the EDQM roadmap for electronic submissions for CEP applications, a major change will be implemented as of 1 January 2020: • eCTD will become mandatory for all CEP applications. • EDQM will stop accepting NeeS submissions for notifications, revisions and renewal applications. Therefore, all such submissions need to be in eCTD format. Changing the electronic format of a …
Information on the ‘Written Confirmation’ process, for active substances manufactured in the United Kingdom (UK), that will be adopted in a no deal Brexit. These guidences can be found here
The number of applications pending, refused and granted for the early access to medicines scheme (EAMS). these tables are updated regularly and can be found on the GOV.UK website here.
EMA is recommending that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not …
The EDQM has revised the following documents to reflect current practice and clarify a couple of items: Terms of reference Code of Practice for the Certification procedure
On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites …
Term and preterm neonates represent the most vulnerable subgroup of the paediatric population with the highest rate of unauthorised or off-label used medicines across the entire paediatric population. The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience …