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Drug Safety

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Latest From Drug Safety

Adverse Event Assessment In India Gets Harvard-Built Tool; Will Increased Trial Activity Follow?

Against backdrop of subdued trial activity in the country and concerns about injury compensation, Indian Society for Clinical Research and Harvard's MRCT Centre offer a portal to facilitate a more objective assessment of causality of serious adverse events.

Drug Safety Clinical Trials

‘Non-Medical Switching’ Claim Riles Europe’s Biosimilars Industry

Two patient advocacy groups have said that a number of issues surrounding biosimilar switching, patient consent and traceability remain to be addressed in Europe, despite growing support for biosimilar use from physician bodies and clinical studies. But the European biosimilars industry has dismissed these concerns, saying that biosimilar medicines will significantly improve access to biologics patients while contributing to the sustainability of pharmaceutical budgets.

Biosimilars Drug Safety

Industry Needs To Submit Fewer Safety Reports, US FDA Official Says

Only 14% of expedited reports sent to FDA's oncology office were informative, CDER's Jarow says, arguing that sponsors 'pull the fire alarm' too frequently.

Drug Safety FDA

Sentinel Offers Drug Firms ‘Unique’ Venue For Post-Market Studies, Pfizer Says

Pfizer’s experience in piloting an approach to using US FDA’s Sentinel data network for post-market research demonstrated the feasibility and benefits of doing so.

Post Market Regulation & Studies Safety

Chlorhexidine OTC Topical Antiseptics Need Allergy Warning

Ingredient in 22 products marketed by 10 firms through NDAs is linked to an increasing number of cases of anaphylaxis.

Drug Safety Consumer

Opana Safety Review Will Set Tone For Opioid Regulation Under Trump

FDA’s 2017 advisory committee calendar is extremely light, but the one product focused review on the schedule should be a doozy: a two-day look at safety issues with Endo’s Opana ER as well as generic versions of oxymorphone. The topic is likely to resonate with the Trump Administration and especially Vice President Pence.

FDA Advisory Committees

EU Mobile App For Reporting ADRs To Be Tested In Burkina Faso And Zambia

An app for reporting adverse drug reactions developed by Europe’s Innovative Medicines Initiative is being tested in two African countries, where the mobile infrastructure is said to be more advanced than in EU. The app is expected to help in the collection of ADR data from malaria programs and from general medicines use.

Regulation Drug Safety

EpiPen Rival Heads Back To Market After kaléo Retools With ‘100% Automated’ Production

Given US FDA’s strict requirements for generic combination products, brand competitors to Mylan’s pricey epinephrine auto-injector such as kaléo’s Auvi-Q might be the best that buyers can expect for a while.

Drug Safety Generic Drugs

Guidance On Acetaminophen Allergy Warning Trails Industry's Change

Final US guidance adds CHPA's suggestion for an example for a warning on labeling for products containing both acetaminophen and aspirin, needed to highlight where “Allergy Alert” and “Liver Warning” statements are on those products' labels.

United States Consumer
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