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The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should preempt state laws on the topic. Read More
A Pennsylvania federal judge dismissed a class-action lawsuit against more than 10 drugmakers that accused them of misrepresenting facts to inflate generic drug prices. Read More
As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from ANDA sponsors seeking earlier meetings to smooth out the review process. Read More
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
Biosimilar sponsors should take a risk-based approach when assessing similarity of a reference product’s quality attributes, the FDA said in new draft guidance — pitched as part of the agency’s effort to lower drug prices. Read More
To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Read More
The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing the previous three months. Read More
Following the destruction brought by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More
Pfizer is suing Johnson & Johnson over its contracts and rebate policies with insurers and hospitals, saying they are designed to block sales of a biosimilar for J&J’s blockbuster Remicade therapy. Read More
The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a formal evaluation. Read More