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Recent PET Drug Inspection Findings Shed Light on Upcoming FDA Focal Points

Recent inspection findings at positron emission tomography (PET) drug manufacturing facilities regarding sterility assurance, testing, training and quality oversight provide insight into what FDA investigators will be looking for when inspecting these manufacturers – most for the first time....

Relationships, Communication Gaps for Atypical Actives Aired at PDA/FDA Workshop

The relationships and the communication gaps between ingredient producers, distributors, dosage form manufacturers and regulators when atypical actives are involved received a public airing at a workshop cosponsored by PDA and FDA in March in Bethesda, Maryland....

Insights from Atypical Actives Workshop Could Drive Needed Technical/Regulatory Guidance, Participants Affirm

The insights that emerged at a PDA/FDA workshop on atypical active ingredients could form the basis for guidance that would clarify the regulatory expectations involved and help close the existing communication gaps in the manufacturing and distribution chain....

China’s Quality Regulatory Process Evolving Toward the Western Model

China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH....

Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA

A proposal for a two-tiered system that would require a biological product to be approved first as a biosimilar and then later become applicable for “interchangeable” status with a reference product using post-marketing data drew attention at an FDA public meeting on November 2-3 at the agency’s White Oak campus in Silver Spring, Maryland....

Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas

TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....

FDA Gathering Biosimilar Stakeholders for Input on Implementing the New Legislation

FDA will be holding a two-day public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation. The meeting is set for November 2-3 at FDA’s White Oak campus in Silver Spring, MD....

Excipient Master File System Advocated for EU

An excipient master file (EMF) system in the EU would facilitate the review process, spur excipient R&D and harmonize with other regulatory systems, advocates are saying....

MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings

Almost one-third of Type IA variation notifications are being rejected by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) due to not meeting the filing criteria or including the right administrative information, according to an assessment by MHRA covering the six months since the new EU variations regulations became effective....

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....
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