UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines. Read more “Did you know the MHRA have published a new guidance on submission of nitrosamine risk evaluations?”
The US Food and Drug Administration (FDA) are debating the creation of a pilot programme to evaluate the toxicology and quality of novel excipients. Read more “Did you know the FDA have proposed a novel excipient evaluation programme?”
A recent document released by the European Commission (EC) outlines Good Practice considerations when assessing genetically modified organism (GMO) related aspects, during the conduct of clinical trials with Adeno-associated virus (AAV) vectors. Read more “What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?”
The United States (US) Food and Drug Administration (FDA) is continuing efforts to evaluate materials such as metals, used in devices, to ensure their safety and efficacy. Read more “How does the FDA plan to address safety concerns regarding metals in medical devices?”
The United States (US) Food and Drug Administration (FDA) has made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical product lifecycle management. Read more “FDA adopts draft ICH guidance for managing post-approval CMC changes”
The United States (US) Food and Drug Administration (FDA) have revised draft guidance on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). The guidance describes points to consider in order to ensure product quality and performance for MDIs and DPIs. It states chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Read more “FDA revises draft guidance on metered dose and dry powder inhalers”
The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Read more “FDA publishes draft guidance on CMC changes to a biologics license application”
The International Council for Harmonisation (ICH) has released a Question & Answers document on its ICH Q11 guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).
In 2016, the European Medicines Agency (EMA) announced the publication of a draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics. Read more “EMA publishes reflection paper for generic oral immediate release products”
The Committee for Human Medicinal Product (CHMP) recently adopted an updated guideline on manufacture of the finished dosage form.