Submission of an application for an animal medicine authorisation
Guidance for the pharmaceutical industry on how to submit applications, data packages and company responses for proposed or existing authorisations in the UK.
Source: gov.uk
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Liberia: LMHRA MD Discloses Outcomes From WA-MRH 11th Steering Committee Meeting
Monrovia – The Managing Director of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Managing Director, Pharmacist Keturah C. Smith-Chineh (Mrs.), recently attended the 11th West Africa Medicines Regulatory Harmonization (WA-MRH
Source: frontpageafricaonline.com
Medicines: get scientific advice from MHRA
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Source: gov.uk
In review: the life sciences regulatory regime in Italy
This article reviews the essential regulatory considerations surrounding medicines and medical devices in Italy, including clinical trials and marketing authorisations.
Source: lexology.com
Clinical Trials FDA Proposes Benefit-Risk Assessment For New Drug And Biological Products
The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket...
Source: clinicalleader.com