Companies can get the European Medicines Agency’s scientific opinion for their products’ use in EU and non-EU countries at about the same time.
The European Medicines Agency has issued new guidance for companies interested in applying for the parallel evaluation of their medicines or vaccines meant for the EU-wide market as well as for non-EU countries under the so-called Article 58 procedure.
The parallel assessment would result in the EMA’s human medicines evaluation committee, the CHMP, adopting a scientific opinion in relation to the drug or vaccine
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.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
