The US FDA clarifies that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities. This clarification is one of several recently announced by the agency.
The US Food and Drug Administration has announced several clarifications on its policies on drug compounding, these include not imposing limits on the amount of compounded drugs pharmacies can distribute over state lines. However, that will change once the FDA and state agencies agree on a final memorandum of understanding (MOU) on interstate compounding.
Another clarification is that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
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.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
