Topic:

Regulatory

Latest Headlines

Latest Headlines

Epigenomics scores Chinese marketing approval for innovative colorectal cancer test

Epigenomics won marketing approval in China for its next-generation colorectal cancer test, moving the company forward on its path toward global commercialization for the product and helping it compete in an increasingly competitive playing field.

India's Zydus Cadila finds blood pressure med has embedded brown spots

The U.S. arm of India's Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.

WSJ examines disclosure of ties between FDA and medical device companies

Many FDA advisory committee members have financial links to devicemakers that they do not publicly disclose, which critics say rips into public trust of the agency.

J&J discount offer wins NICE over to new use for Stelara

The National Institute for Health and Care Excellence decided to reverse course on a new use for Johnson & Johnson's anti-inflammatory drug Stelara, thanks to a new discount offer.

FDA notches a win after Tennessee compounder pleads guilty

The FDA closed another chapter in regulating errant compounders when the co-owner of Main Street Family Pharmacy, a Tennessee-based compounding pharmacy, pleaded guilty in federal court to a misdemeanor criminal violation related to a contaminated steroid that caused 26 people to become ill.

European watchdogs pull Mylan, Abbott generics on contractor's data problems

Here's another black mark against the pharma industry in India. European regulators are barring a slate of generic drugs whose approvals relied on data generated by India's GVK Biosciences. The treatments weren't named, but they include products sold by a variety of drugmakers, including U.S.-based Mylan and Abbott Laboratories.

J&J gains FDA clearance for rare pediatric spinal device

The FDA has cleared the VEPTR and VEPTR II Vertical Expandable Prosthetic Titanium Rib Devices to treat children with thoracic insufficiency syndrome, a rare congenital condition that results in severe deformities of the chest, spine or ribs that impair breathing and lung growth.

Documents reveal FDA's use of computer forensics to uncover data falsification

In 2011, a Sun Pharma technician gave into temptation, hit the delete key and generated new, positive data from another sample within the same batch. In 2013, the FDA uncovered what had happened and tasked its computer forensics experts with finding other such events. The team discovered 5,301 more deleted chromatography results from the same facility.

EU nations yank drugs over GVK data scandal

Some European Union states have suspended the approvals of drugs tied to a data falsification scandal at CRO GVK Biosciences, and the European Medicines Agency is investigating whether to recommend a continental halt.

Report: New FDA policy on animal antibiotics has loopholes

The Pew Charitable Trust has released a report revealing that significant gaps in labeling of some products effectively allow farmers to give antibiotics to their animals under the guise of "disease prevention," when they're really using the drugs for growth promotion.