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Regulatory authorities participating in the international Pharmaceutical Inspection Co-operation Scheme are concerned that the European Commission’s proposed good manufacturing practice guideline on advanced therapy medicinal products diverges from PIC/S requirements and will result in lower regulatory standards. The commission defends its approach, saying the guideline will result in high-quality ATMPs and ensure patient protection.
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High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.
A warning FDA submitted March 16 says Opto-Pharm's "Buffered Eye & Skin" product – distributed in the US by Cintas under the Xpect and First Aid Direct brands – are not labeled or formulated in accordance with the agency's ophthalmic drug products monograph.
A bill implementing the provisions of the EU-Canada CETA trade deal is expected to be approved soon, bringing a new Certificate of Supplementary Protection together with an export manufacturing waiver, and some changes to the patent litigation system.
A pharmaceutical industry official said while it is not too late, manufacturers that have not yet started risk assessments to comply with ICH Q3D for legacy products need to get busy. Official also advised that good risk assessments should make it easier to comply and reduce the need to retest products if new metals are introduced into the manufacturing process.
A new package of measures from the European Commission will introduce an SPC export manufacturing waiver to help improve the competitiveness of Europe’s generics and biosimilars industry, while originator companies should benefit from steps to smooth out the rules on the “Bolar” research exemption and implement an EU-wide SPC.
Jury convicts Barry Cadden on racketeering and mail fraud allegations for shipping contaminated methylprednisolone acetate for spinal injection, but clears NECC's head pharmacist on all 25 counts of second degree murder in seminal case that spurred legislation enabling major US FDA crackdown on injectable drug compounding sterility assurance practices.
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