Compliance

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

Cipla reports highest ever quarterly revenues in the US, a market that’s seeing lower “price compression” amid sell-offs, bankruptcies and a rebalancing of the supply chain. The firm’s portfolio has a “lot of steam” left to be unlocked and it’s also keeping an eye on the impact of the tornado-hit Pfizer site on supplies.

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document sheds some useful light.

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says. 

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.

Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.

This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.

When a medtech regulatory consultant receives some 500 requests in a single month on LinkedIn for a guide he has spent 300 hours writing, you know it is a critical topic.

Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.

The US FDA has published draft guidance for predetermined change control plans for medical devices along with recommendations for sponsors including them in marketing submissions to the agency.

It is “absolutely fundamental” that manufacturers of cell and gene therapies interact with inspectors from regulatory agencies to understand their expectations around good manufacturing practice, a compliance consultant at CDMO eXmoor pharma says.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.