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For companies in highly regulated industries, compliance is second only to survival as a business. Yet why do so many companies struggle with compliance? Dr Rebecca Godfrey explores this issue and provides practical steps that companies can take to ensure best practice.
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
The House of Representatives has voted to approve Speaker Pelosi’s drug pricing bill in a Democrat-led chamber, say reports.
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
The amount of illegal diazepam tablets commandeered at the border of the UK doubled last year, according to a report.
US prosecutors have handed subpoenas to six pharmaceutical companies and distributors for their role in the opioid crisis, as reported.
US Speaker Pelosi’s new drug pricing plan could impact small biotech companies, reducing their innovation by 90 percent, says new research.
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
Donald Trump has issued a statement outlining a plan to make drug costs in the US clearer for patients, which could also help to drive competition.
A US appeals court has upheld a ruling that threw out a $2.54 billion jury verdict Merck won against Gilead over hepatitis C treatments.
Allergen is to reportedly settle a class-action lawsuit which alleges that it worked to delay generic competition for Alzheimer’s disease therapy Namenda.
Teva has agreed to supply opioid medication and make a cash payment in a settlement agreement that removes it from the Track 1 opioid litigation.
A jury has said that Johnson & Johnson must pay $8 billion in the case over male breast growth linked to Risperdal.
Drugmakers that face litigation over the opioid crisis are looking at ways to settle the cases by using Purdue's bankruptcy, it has been reported.
