After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
Johnson & Johnson is battling another onset of quality concerns as its subsidiary Janssen is pulling one lot of its Risperdal Consta injection in the US due to a mold contamination.
Regulators in Southeast Asia say draft process validation guidelines issued for consultation last week are a work in progress and likely to change as discussions continue.
The global pharma packaging market - worth $47.5bn (Eur35.87bn) in 2011 - is expected to grow to $73bn in 2018, with a CAGR of 5.6%, according to a report by Transparency Market Research.
inVentiv Health company Adheris filed a lawsuit against the US Department of Health and Human Services (HHS) last week claiming that a new regulation imposes unconstitutional restrictions on part of its patient reminder business.
As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
Mylan announced on Tuesday that it received approval from Indian regulators to acquire Agila for $1.6B just as a recent report from India’s Parliament criticizes foreign companies’ increasing control of the industry in the country.
The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.
The US FDA has sent a warning letter to CRO Drug Research and Analysis Corp. founder and president Henry Frazer for failing to adhere to the agency’s regulations governing clinical trials.
Chinese Police say GSK China rather than individual salespeople organised alleged bribery of doctors that is currently being investigated by the country's authorities.
The US FDA and EMA still disagree on some aspects of QbD, but collaborations like their recent pilot scheme can only be a good thing for industry according to a former MHRA assessor.
Cubist is issuing a nationwide recall of four lots of its antibiotic injection Cubicin after one of the company’s CMOs had a manufacturing issue that caused glass particulates to contaminate the lots.
Rapid growth in demand for pharmaceutical storage solutions could lead to Yusen working with its competitors, the firm says as it opens a 40,000m2 warehouse in Thailand.
Being pipped to the post by the cast of Sesame St is rarely a positive, but when it means Outsourcing-pharma.com's tech team has the time it needs to develop an iPhone App as good as the one launched this week then it's OK.
Description of the manufacturing process in regulatory submissions must be the same whether the applicants use Quality by Design (QbD) or the traditional approach, the FDA and EMA have concluded.
Covance has upgraded blood tube processing and kit production capabilities at its US central labs unit and says the efficiency drive is helping sponsors make better decisions.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.
The TransCelerate BioPharma industry group has launched its clinical trial comparator network to establish a reliable means for sourcing quality drugs for clinical trials.
Early phase CRO Velesco Pharma has opened a new business development office in the greater Boston area to be closer to its existing and prospective clients.
As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
The US FDA has finalized guidance on clinical trial oversight, calling for more remote and targeted risk-based monitoring, though some experts believe such monitoring should be more judiciously employed.
Lonza has granted access to its potency boosting expression system to antibody developer Sorrento Therapeutics just days after a signing a similar deal with Pfizer.
A lack of understanding and commentary on proceedings may be putting some pharma firms off opting into the UK’s Patent Box scheme, according to a legal expert.
Strides Arcolab received a US FDA Form 483 for an injectables facility that provides for about 25% of subsidiary Agila’s revenues, which is currently in the process of being acquired by Mylan.
The Supreme Court of India late last week ordered all state government health secretaries to meet with the national Secretary of the Ministry of Health to discuss ways to strengthen the framework for regulating clinical trials.
Ireland-based commercialization services firm United Drug has announced plans to buy Spanish contract pharmaceutical sales group Expansis for €12m ($15m).
Building on similar European documents, Australia’s TGA (Therapeutic Goods Administration) released guidance Tuesday to help assist drugmakers looking to win approval for their biosimilars.
The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.
The latest survey of clinical trial investigators found almost half most prefer to work with Covance’s central laboratories while nearly a quarter said they preferred Quintiles.
Management and staff involved in manipulating quality data during an FDA inspection have been sacked by Fresenius Kabi as part of remediation actions at its Indian API facility.
inVentiv Health’s medical communications business is opening two new offices in Tokyo and New York City to be closer to clients and integrate further with the company’s clinical teams.
The days of using Excel spreadsheets to manage clinical trial site payments are now in the past, especially as CROs and sponsors look to retain their most highly-prized sites and establish long-term relationships for future trials.
Chiltern has a new Director of Global Pharmacovigilance and there's an appointment at DSM in this week's lowdown on the outsourcing industry's movers and shakers.
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.
