In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
The EMA looks to the future by posting its five key priorities to address in the coming five years, which includes the need to recruit expertise in ‘novel manufacturing technologies’.
MediLedger Product Verification Solution, a DSCSA compliant platform, is announced that will assist drug supply chain stakeholders in product verification and authenticity.
Altaire instigates voluntary recall of sterile ophthalmic treatments, after concerns were raised about QA processes in place at its manufacturing facility.
Xellia will move US production from its North Carolina manufacturing facility to its site in Ohio to bolster workforce and manufacture generic IV antibiotics.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment.
Lonza expands its HPAPI production capacity at its Switzerland facility after entering an agreement with AstraZeneca, and invests in manufacturing to establish efficiency.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
Insys announces that it will file for Chapter 11 bankruptcy following the settlement of a legal case regarding its sales tactics for its opioid-based pain killer.
The US FDA approves Merck’s application to expand the label of Zerbaxa for the treatment of hospital-acquired infections to address ‘global challenge’ of AMR.
EMA assembles pharmaceutical developers to strengthen antimicrobial pipelines while, in the meantime, a study found the world’s rivers dangerously contaminated.
Although the industry may not be among the ‘frontrunners’, Novo Nordisk is seeing the benefits when it comes to recruitment and developing mutually beneficial partnerships, says director.
US FDA grants approval for Novartis’ Piqray to be used as combination treatment for advanced or metastatic breast cancer, a potential blockbuster drug.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
