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September 22, 2022
Guidance for the pharmaceutical industry on how to submit applications, data packages and company responses for proposed or existing authorisations in the UK.
June 8, 2022
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
March 25, 2022
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
February 23, 2022
This article reviews the essential regulatory considerations surrounding medicines and medical devices in Italy, including clinical trials and marketing authorisations.
February 11, 2022
The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket...
February 11, 2022
The FDA's draft guidance illustrates how a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket...
December 28, 2021
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October 29, 2021
Guidance on how to licence electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
September 28, 2021
Pharmaceutical manufacturers have been submitting applications electronically to FDA for years. So the agency’s announcement that it intends to switch its cur
February 16, 2021
German NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO. Pivotal 6-month data readout for vamorolone in Duchenne muscular dystrophy (DMD) expected in the second quarter of 2021 Organization streamlined with a focus on cost savings and progressing vamorolone Preliminary unaudited result for 2020: net sales CHF 15.0 million; net loss CHF 71.2 million; cash on hand as of December 31, 2020, CHF 12.4 million Upsiz...