In this week’s news, the US HHS wants to change BA/BE trial rules, GAO wants Covid-19 trial data pooled and more…
US HHS proposes BA/BE study framework and new labelling rules
The US HHS wants to harmonize generic drug equivalence trials and tweak rules of “patient labelling.”
The US Department of Health and Human Services (HSS) proposed the bioavailability and bioequivalence study changes in the Federal Register, explaining the idea is to provide a framework.
“The proposed rule would specify needed basic study conduct requirements to enable FDA to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies,”
The HHS also proposed changes to “patient labelling” – on pack instructions explaining how a drug should be used in an outpatient setting.
The changes call for “clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively,”
US FDA has published its new OTC fee structure
The US FDA will charge contractors that make OTC drugs almost $14,000 per facility under a new fee structure.
The regulator announced its 2021 fees for firms that submit products through its over-the-counter (OTC) monograph drug user fee program (OMFUA).
For an OTC CDMO facility – defined as a facility where neither the owner nor any affiliate sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers – companies must pay $13,548.
The FDA also confirmed it no longer plans to charge companies that registered with FDA as OTC drug makers solely to produce hand sanitizers during Covid-19 pandemic.
Originally the FDA planned to charge firms that stepped up to make sanitizers. However, the outcry after it announced the plan in December prompted a change of heart.
Also in the news
US Government lawyers have raised concerns about FDA biologics facility inspections after allegations the agency improperly downgraded results. Read more at RAPS.
The US Government Accountability Office has called for data from Covid-19 vaccine and therapy trials to be centralized according to Politico.
The Wall Street Journal reported that Pfizer is working on a version of its vaccine that does not require ultra-low temperature storage.
The EU has concluded that AstraZeneca’s coronavirus vaccine does not increase the risk of blood clots. Read the full Reuters report.
Packaging Digest reported that Jabil Healthcare and E3D have teamed up to in a drug delivery device development agreement.
STAT looked at events likely to shape the biotechnology sector for the rest of the year (subscription).
Some developments of note in the contracting sector:
Vaxcyte says capacity constraints at CDMO and Covid-19 related disruption have caused it to delay pneumococcal vaccine IND submission. See more at Bioprocess Insider.
SK Capital has bought Catalent’s blow-fill-seal business. Read the full story at Contract Pharma.
GSK will play CDMO for Novavax after agreeing to provide fill and finish manufacturing capacity for the latter’s Covid-19 vaccine at its Barnard Castle facility. See press release.
Astrazeneca has expanded its agreement with Ajinomoto Bio Pharma Services to include the provision of aseptic fill finish services at the CDMO’s San Diego, California facility. See press release.