USA – FDA establishes advisory committee for genetic metabolic disease treatments
The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under...
Germany – Germany will revise laws for clinical trials with pharmaceuticals, medical devices and...
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented...
Europe – ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for...
EMA’s Emergency Task Force (ETF) considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for primary...
Europe – EMA proposes new guideline on non-inferiority trials
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.
The CHMP adopted a positive opinion for Omjjara* (momelotinib),...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
USA – MedCon: TAP pilot off the ground four devices enrolled
The US Food and Drug Administration (FDA) has enrolled the first four devices in its Total Product Life Cycle Advisory Program (TAP) pilot, while...
USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
The US Food and Drug Administration (FDA) recently published a final guidance on its process for granting – or denying – waiver, exceptions and...
Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
