In a notice of proposed rulemaking published in the Sept. 23 Federal Register, FDA proposed deleting the acid neutralizing capacity test for antacids that is currently contained in the OTC antacid final monograph, and replace it with the U.S. Pharmacopeia's procedures for determination of antacid acid neutralizing capacity. The revision is being proposed, the agency said, to align the monograph with the USP compendia and because the USP test "is appropriate" for determining acid neutralizing capacity. Comments on the proposal are being accepted until Nov. 22.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.
