Topic:

Regulatory

Latest Headlines

Latest Headlines

American Optometric Association takes beef with eye test app to FDA

The American Optometric Association (AOA) is hopping mad at eye test maker Opternative for allegedly marketing its product without proper approvals, and now the group wants the FDA to jump into the fray. The AOA is urging regulators to take legal action against Opternative for selling a test that leads to an eyeglass or contact lens prescription without an in-person exam by an eye care professional.

UPDATED: Samsung Bioepis aims at AbbVie Humira patents in U.K. lawsuit

Incheon-based Samsung Bioepis has aimed a U.K. lawsuit at AbbVie's Humira patents as it races to bring a slate of biosimilars to the market that includes the blockbuster rheumatoid arthritis therapy in the face of sharp-elbowed competition to do the same.

Rusan plant in India remains under EU ban due to persistent GMP problems

Four years after U.K. regulators issued a ban on products from a Rusan Pharma site in India, inspectors found that nothing has changed, or at least not enough for the company to escape the manufacturing suspension imposed in 2012.

Startup wins PMA approval for direct-visualization, endoscopic ablation for afib

CardioFocus has nabbed an approval from the FDA for its HeartLight Endoscopic Ablation System to treat paroxysmal atrial fibrillation.

Drugmakers see no marketing leverage from FDA biosim guidelines

Drugmakers had high hopes for the FDA's biosimilars labeling guidance; both reference-product drugmakers and copycats figured they might be able to use biosimilar labeling to their marketing advantage, depending on the language. But no dice, the FDA said late last week.

PwC: Biopharma must turn to tech to address surge in data integrity violations

Over the past few years, regulators have frequently found fault with data integrity at manufacturers and CROs, which have been accused of everything from logging discrepancies in uncontrolled Excel files to the duplicating of electrocardiogram results. In response, PricewaterhouseCoopers is calling for adoption of technologies to identify and prevent fraudulent activities.

Alibaba Health drops China online pharmacy plans, blames complex regulatory environment

Exactly one year after Alibaba announced it wanted to integrate its pharmacy business into its health unit and sell more drugs online, the Chinese e-commerce giant has now dropped its plans citing growing concerns over its country's healthcare landscape.

Samsung Bioepis gets positive CHMP opinion on Remicade biosimilar

Incheon-based Samsung Bioepis won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its Remicade biosimilar, paving the way for more competition in reimbursed markets in Europe.

CMS report adds more pressure on embattled Theranos and its blood testing device

What began as a bad week for embattled blood-testing company and former Wall Street darling Theranos veered toward worse yesterday when a federal inspection report was released, finding the accuracy of the company's revolutionary device consistently failed to meet even its own standards.

Congressional investigation says tainted Chinese heparin may still be in U.S.

In 2008, contaminated raw heparin from China was tied to the deaths of dozens of U.S. dialysis patients, leading the FDA to realize it needed inspectors in China to oversee manufacturers. But a House investigation, launched that year and still ongoing, is questioning whether the FDA has done enough and whether the tainted heparin may still be getting into the U.S.