The FDA Guidance on End-of-Phase 2A Meetings (EOP2A) has now been published in the federal register after a one year public comment period. EOP2A meetings are implemented to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design. Read more.
The period for registering for the pilot programme for biotechnological products in order to submit the CMC part in consideration of the QbD approach has now been prolonged by the FDA until 30 September 2010. Find the details here.
The procedure with regard to FDA Warning Letters has changed. The authority now expects an appropriate reply within a very short time frame. New is - among others - the "Close Out Letter" as well as the revised FDA website. Read more here.
The US Food & Drug Administration (FDA) has published a draft with regard to GMP Rules for Combination Products. These are products consisting of a combination of a medical device, a drug and/or a biological product. Read more here.
A recently published article of the Pharmacopeial Forum (Vol. 35(5)) suggests additional testing of parenteral products. This testing is supposed to be conducted randomly according to the 100% control in the process and to substantiate the required "essentially free" of visible particles. Read on here.
The EDQM suspended CEPs of an Indian manufacturer of active pharmaceutical ingredients on the grounds of GMP deficiencies in manufacture. Subsequently, the Dutch medicines authority removed the manufacturer from the authorisation files with the substances in question. Read more here.
The authorities place increasing emphasis on the continuously growing challenges of the global supply chain and its supervision. Read more about the expectations of the FDA and of the European authorities.
The supply chains for excipients stretch around the entire globe. This makes it all the more important for the excipient-sourcing and -processing companies to secure these supply chains among other things with correct and complete quality agreements. IPEC Europe has published a new guideline on this subject. Read the details here.
The Guideline which will become effective on 1 January 2010 addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. Read more.
The US Pharmacopeia (USP) published a new general chapter <1235> Vaccines for Human Use - General Considerations in the section In-Process Revision. It provides background information on manufacturing and tests of vaccine monographs. Read more here.
Topical questions and answers on ICH Q8, Q9 and Q10 were published by the EMEA at the end of June. With this document, the requirements laid down in the three guidelines are meant to be implemented and interpreted in a harmonised way in the three ICH regions. This link will lead you on.