With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
The topic of antimicrobial resistance is back in the spotlight after the US FDA released a new website and a number of proposals to encourage the drug development in the area.
The US FDA announced a number of measures it considers as a viable means of combatting AMR, including the idea of hospitals paying a ‘subscription’ to access new medicines.
As Novartis looks to sell a major chunk of its generics portfolio in the US, in-PharmaTechnologist has a look back at some of the stories this year that have signposted larger, on-going trends in the US generics market.
The US FDA’s inspection of Lupin gave its manufacturing process for its ‘sartan’ products the all clear but managed to find one “procedural deficiency”.
The FDA has announced that a lot of montelukast sodium tablets has been discovered to contain a different type of medicine, potentially posing health risks.
The US FDA has rejected Mallinckrodt Pharmaceuticals’ investigational candidate, stannsoporfin, intended for the treatment of newborns at risk of jaundice.
The US FDA has granted expiration date extensions for specific lots of Mylan’s EpiPen auto-injectors, as manufacturer Pfizer works to stabilise supply.
Industry executives are welcoming the FDA’s draft guidance on expansion cohort use in first-in-human clinical trials – the increasing use of which is evidence of a changing drug development paradigm, says CRO.
Apotex had seemed to be having a good week after it received US FDA approval for its generic product, only for it to then be on the receiving end of a warning letter the following day.
The latest regulatory update in the valsartan recall saga comes from the US FDA, which has published Form 483s relating to inspections at Zhejiang Huahai plants in 2016 and 2017.
In a second quarter call with investors, president of Mylan, Rajiv Malik, stated the company has undertaken a restructuring and remediation plan at its Morgantown, West Virginia plant.
The FDA guidance addresses EHR data use in clinical trials – and while “one of the most prescriptive in recent memory” – does not solve interoperability challenges or address other sources of data, such as wearables.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
The US FDA has drawn industry attention to the potential of 3D printing and continuous manufacturing, which it says could “improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the US”.
“Arbitrary upper age limits for trial entry are almost never justified,” says FDA, which has renewed its efforts to include older adults in clinical trials and tackle some of the key enrollment challenges.
The first ever drug to treat smallpox has been approved by the US FDA, after having been created by SIGA Therapeutics in coordination with several US departments.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
BioIVT adds transporter assay products and services to its ADME-Toxicology portfolio with the acquisition of Optivia Biotechnology – a deal which aligns with the company’s efforts to support drug safety and efficacy, says VP.
The US FDA has issued a policy that provides the proper definition of an outsourcing facility in an effort to ensure compounded drugs are made under appropriate quality standards.
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.
Fresenius Kabi says drug ingredients made at an Indian plant hit with a US FDA warning letter meet quality specifications and has reiterated that tests were halted for technical reasons.
The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.
Cannabinoid firm GW Pharmaceuticals says it is “inspection ready” as it prepares for potential US approval of its epilepsy candidate Epidiolex (cannabidiol or CBD).
