05-Dec-2013 - Drugmakers seeking ANDAs for certain solid dose, extended-release drugs will need to test what impact alcohol has on their products under new draft guidance on bioequivalence issued by the US FDA.
05-Dec-2013 - A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
03-Dec-2013 - Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
02-Dec-2013 - A drug industry supply chain group has welcomed the introduction of new US laws designed to make it easier to track pharmaceuticals through the supply chain.
28-Nov-2013 - The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.
27-Nov-2013 - Actavis says it is restructuring a Californian manufacturing facility at a cost of 56 jobs weeks after the announced closure of a plant in North Carolina.
27-Nov-2013 - The US Food and Drug Administration (FDA) has hit Wockhardt with a second import alert this year, this time at its Chikalthana, India facility.
21-Nov-2013 - The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
19-Nov-2013 - US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill” last night.
19-Nov-2013 - An industry group has called for greater regulatory harmonization in South America, arguing that both the drug industry and patients would benefit.
18-Nov-2013 - US Senators will debate pharmaceutical track and trace legislation later today in a session that could have a dramatic impact on how drug supply chains in the country are monitored.
07-Nov-2013 - Remediation at troubled Rocky Mount facility will continue into 2014 Hopira says as it awaits an inspection by the US Food and Drug Administration (FDA).
07-Nov-2013 - The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept of quality-by-design (QBD) that focuses mostly on design space verification.
06-Nov-2013 - The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China.
05-Nov-2013 - In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal and civil liability.
05-Nov-2013 - Payers should keep pharmaceutical firms’ quality records in mind when making purchasing decisions to help prevent drug shortages and stimulate manufacturing innovation according to the US FDA.
05-Nov-2013 - An IPEC-affiliated coalition is calling on USP (US Pharmacopoeia) to allow for the determination of physiologically relevant bioaccessible elemental impurity content for pharmaceutical products and components.
29-Oct-2013 - Novo Nordisk has recalled 30 batches of a prefilled insulin product following a dosage error at a manufacturing facility in China.
28-Oct-2013 - Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.
21-Oct-2013 - Drugmakers, fine chemicals firms, delivery technology manufacturers and processing system developers from around the world meet in Frankfurt, Germany.