Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.
A blue binder containing batch records for US-bound drug products was among the unreviewed documents, some dated as recently as a week before the facility inspection, that a US Food and Drug Administration investigator discovered in a 55-gallon drum in a Puducherry, India, drug manufacturing plant’s scrap yard.
The investigator saw other good manufacturing practice records during a 28 January to 5 February 2019 inspection of the
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.
