In this week’s news, new US FDA guidance docs, concerns over “CRISPR babies” paper, details of US compounding crackdown and more…
Raft of US guidance docs on biosims, generic labelling and data integrity
The US FDA’s regulatory division has had a busy week, having issued draft and final guidance documents on subjects ranging from manufacturing to biosimilars.
The documents – which are available here – set out the agency’s expectations for submission dossiers and are designed to help developers successfully navigate approval and compliance.
A new Q&A document about biosimilars is one of the most eye catching publications. It clarifies several requirements introduced in the 2009 Biologics Pricing and Competition Act (BPCI).
The agency also published the final version of its GMP-related data integrity guidance. The document includes 18 questions on data-related topics covered by 21 CFR parts 210, 211 and 212.
In addition, the FDA announced it has dropped a 2013 plan to let generic firms to update drug labelling to reflect new safety information without waiting for the reference product’s label to be revised.
The agency citied non-branded drug firms’ concerns about access to safety data and potential liability as the basis for its rethink.
Controversy surrounding “CRISPR babies” study
A researcher who claims to have used the CRISPR gene editing technique to modify the genome of an embryo such that it is resistant to HIV is seeking to publish details of the study.
According to various reports, researcher He Jiankui has submitted the so-called “CRISPR babies” study to several journals for review.
In its coverage STAT pointed out the ethical concerns associated with this research. It also noted Jiankui already had a similar paper – focused on engineering embryos to prevent heart diseases – rejected this year.
FDA comments about efforts to ensure the quality of compounded meds
The US FDA has updated on efforts to ensure the quality of compounded drugs made by pharmacies and CMOs.
Commissioned Scott Gotlieb and Deputy Commissioner Anna Abram shared details last week, explaining the aim is to preserve access to compounded drugs while protecting patients from contaminated or harmful products.
“Compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA-approved drug product, it’s important to understand that compounded drug products haven’t undergone FDA premarket review for safety and effectiveness.
“Compounders who are uniquely permitted under law to compound and distribute certain compounded drugs without receiving patient-specific prescriptions are referred to as outsourcing facilities” they wrote.
Also in the news
The Medicine Maker looked at potentially harmful immune responses to biologics drugs and how the pharmaceutical industry is working to address them.
Bioprocess Insider presented a roundup of manufacturing shutdowns that have occurred this year. The article also covers industry-wide production capacity.
The UK Charity Commission has tweaked its rules to require complementary therapy providers seeking charitable status to provide more detailed scientific evidence of the benefits of their services.
US drug industry organisation DCAT has reviewed industry demand and CMO sector capacity. The study is available here.
And Capstoneheadwaters has taken a look at biopharma and cell and gene therapy outsourcing in Q4.