Tag Archives: Regulatory

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
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FDA Push for TRF Therapies Will 'Disrupt Pain Market'

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan. The opioid market is currently dominated by non-tamper resistant formulations (TRFs), but FDA’s promotion of TRF therapies “could well result in the departure of non-TRF therapies from the market and shake up its structure.” Unless FDA mandates TRF therapies, […]
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UK Plan for Rare Diseases: Little Focus on Access to Medicines

By Leela Barham. The European Commission mandated that all member states have a plan for rare diseases back in June 2009. With the EC deadline just weeks away, the UK has now finalized its own. But for those who were hoping it would have a clear focus on access to medicines, there’s little to be […]
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Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
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$20 Billion 'Lifestyle' Market Immune to Costly Regulations, says Alphaeon CEO

You can’t defraud the government if you aren’t handling its money, explains Robert Grant, CEO of Alphaeon, a lifestyle healthcare company. Pharma free-market advocates take note. If you no longer had to worry about the Anti-Kickback Statute, Stark Law or the Sunshine Act, would your professional marketing strategy change? Probably, if you like making money. […]
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