OTC and supplement firms that must include slack fill in products should document reasons why as a defense in future class action cases, says attorney Elizabeth Chiarello. Transparent packaging and fill lines also protect companies, she says.
OTC drug and dietary supplement marketers should document their reasons for not filling products to the brim in the event they face slack fill complaints, says attorney Elizabeth Chiarello.
Chiarello, a partner in the Chicago office of Sidley Austin LLP and a specialist in class action and product liability,...
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
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
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.
CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.
The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.
