‘Complete Response’ Letters
Details of action letters issued by FDA, regularly updated with new announcements.
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The entry of India’s state-owned Indian Immunologicals and partner Griffith University in the COVID-19 vaccine race could potentially disrupt pricing dynamics. The alliance is developing a live-attenuated, single dose vaccine, which it hopes will be ready for launch in 18-24 months.
Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.
The UK's MHRA is looking for manufacturers to submit COVID-19 self-tests that meet minimum and desired criteria for evaluation, after finding its recently purchased 3.5m self-tests failed to meet these standards. Criteria include no requirement for testing knowledge or training or assistance from a healthcare professional in administering or interpreting the results of the test, as well as a 95% accuracy level.