FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.
Gilead Sciences Inc.’s pursuit of a pre-exposure prophylaxis claim for Truvada has raised a novel risk management challenge for FDA: whether and how to restrict access to a drug for preventing HIV infection when the same agent, and its individual components, is approved in the same dose and without restrictions for treating the disease.
The logistical challenges involved in adding distribution restrictions for a supplemental indication – and the potential ramifications on end-users, the...
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
