Topic:

Regulatory

Latest Headlines

Latest Headlines

Health Canada bans Hospira drugs coming from Italy plant

Two months ago, the FDA issued a warning letter for a Hospira plant in Italy noting a number of problems including its lack of controls for access to prevent data deletions from test equipment. Health Canada has decided that issue is enough for it to ban products coming out of the sterile manufacturing facility.

Deputy at China agency that probed GSK arrested for corruption, report says

The deputy head of China's State Administration for Industry and Commerce has been arrested for corruption, putting an agency that was at the center of the GlaxoSmithKline bribery probe into its own spotlight.

China plans to ensure private hospitals get subsidies, finance

China has moved to flesh out guidelines for an expansion of private hospitals by allowing subsidies and finance to flow to new companies as a way to allow patients access to newer services and ease demand on the public system.

Merck KGaA partner Genea gets CE mark for a pair of IVF technologies

Genea Biomedx partnered its three fertility products in development with Merck KGaA last month. Now it's won a CE mark for two of them: the Gavi automated vitrification instrument and the Geri benchtop incubator.

Micro-cap Accurexa gains on FDA submission for brain therapeutic delivery device

Accurexa believes it has the makings for better brain surgery with its therapeutic delivery device BranchPoint. The company has submitted it to the FDA for 510(k) clearance; it allows for the insertion of therapeutics, such as stem cells or oncology drugs, to multiple sites in the brain via a single penetration point with the radial deployment of a flexible catheter.

India's Polydrug Labs criticized for contaminated APIs

When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.

PatientsLikeMe, FDA partner up to track online drug safety clues

PatientsLikeMe teamed up with U.S. regulators on a safety-monitoring project, hoping to pinpoint a new med's risks and benefits sooner than the FDA's current surveillance program does.

FDA upgrades standing of Jubilant U.S. sterile plant cited in 2013

In late 2013, Jubilant Life Sciences ran into trouble with the FDA over problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA, which the agency considered serious enough that it issued a warning letter. But after 18 months of work, the Indian company said the FDA has upgraded the plant's standing.

Ariosa Diagnostics scores CE mark for prenatal test software

Roche's Ariosa Diagnostics nabbed a CE mark for software for its noninvasive prenatal test, a win for the company months after it scored expanded coverage for the tool in the U.S.

FDA taps PatientsLikeMe to harness patient info for drug-safety monitoring

PatientsLikeMe has been on a roll as of late, inking deals with biopharma giants such as AstraZeneca, Genentech and Biogen to provide its patient-reported data for the companies' R&D initiatives. Now the company is shifting gears, planning to work with the FDA to see how its patient reports could improve drug safety.