FDA Pharmaceutical and Medical Device Headline News

Troubled sterile injectable maker Ben Venue Laboratories is extending its voluntary manufacturing pause as major reconstruction in one wing of its now shuttered Bedford, Ohio, plant will take nine months to complete.Read More

Reducing costs in tough economic times is tempting, but drug and device manufacturers should not cut corners when it comes to process validation — especially after release of the FDA’s final process validation guidance, experts advise.Read More

Device-related adverse events are increasing in the EU, with the most recent numbers showing a 13 percent rise in the UK to 10,280 in 2010.Read More

Drugmakers and industry trade groups are calling for speedy passage of the Prescription Drug User Fee Act (PDUFA) with few amendments outside the agreed-upon goals letter.Read More

A federal appeals court has lifted an injunction that barred Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox — a decision that has yet to be finalized but that has emboldened the partners to launch the generic “immediately.”Read More

Biogen Idec and Elan are changing the U.S. label for multiple sclerosis (MS) drug Tysabri to add anti-JC Virus (JCV) antibody presence as a risk factor for developing a rare brain infection.Read More

U.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states.Read More

The U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations.Read More

FDA Commissioner Margaret Hamburg is adopting eight proposals for improving public access to compliance and enforcement data, including ways to speed data disclosure.Read More

While the global generics market is set to surge over the next five years as patents for blockbuster drugs expire, generic-drug makers would be wise to pad their portfolios with specialty products that are more difficult to produce, a new consultancy report states.Read More

The FDA is updating bioequivalence (BE) guidelines on more than five-dozen drugs as it develops online product-specific BE recommendations for generic-drug sponsors.Read More

The first blood test that can measure multiple sclerosis (MS) patients’ risk for a rare but serious brain infection got FDA clearance Jan. 20. Quest Diagnostics’ Stratify JCV antibody test is the first blood test for qualitative detection of polyomavirus John Cunningham virus (JCV) antibodies.Read More

Australian devicemakers are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code. Read More

The FDA’s alleged monitoring of the personal emails of employees who voiced product safety concerns to Congress could dissuade other staffers from airing grievances, industry experts tell DID.Read More

The Medicare Payment Advisory Commission (MedPAC) has voted to recommend changing copays for low-income Medicare enrollees to encourage generic-drug substitution.Read More

The FDA is suing drug- and dietary supplement-maker Syntec and ordered U.S. marshals to seize its products, citing manufacturing violations and false and misleading health claims.Read More

CDRH’s 2012 priorities include a strong focus on innovation and the device approval process, a strategic report shows.Read More

A group of medical device experts from EU member states would oversee device regulation in the union, according to one proposal in a recent “roadmap” released by the European Commission’s Directorate-General for Health & Consumers.Read More

The FDA has approved Amylin’s and Alkermes’ Type 2 diabetes drug Bydureon, marking the end of a long and rocky review path for the drug.Read More

A federal judge has dismissed a failure-to-warn lawsuit against Mylan, saying the generic-drug maker was preempted from making safety label changes even though its generic was the reference listed drug (RLD). Read More

Patent reform in the U.S. and EU, pricing pressures in numerous countries, increasing competition from emerging markets in Asia and Latin America and the global offensive against fake drugs, IPRM followed these issues and more to ensure that readers have the information they need to make smart business decisions in the U.S. and abroad.Read More

House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.Read More

Whether it’s regulatory reforms in the U.S. and Australia, new regulatory frameworks in emerging economies, regulatory guidances and harmonization activities or medtech taxes by cash-strapped governments, IMDRM spanned the globe in 2011 to bring readers useful, up-to-date information on international medical device regulations.Read More

Primary endpoints for Phase III clinical trials of combination products used to repair knee cartilage should be either improvement in physical function or reduction of pain, according to an FDA final guidance.Read More

As promised, the FDA last year moved to tighten up loose links in the global device supply chain while addressing criticism that agency decisionmaking is too often opaque.Read More

Par Pharmaceutical’s First Amendment suit against the FDA is based on false assumptions and misinterpretation of marketing regulations, the agency says, firing back at Par with a motion to dismiss the complaint. Read More

The Medicare Payment Advisory Commission (MedPAC) has voted to recommend changing copays for low-income Medicare enrollees to encourage generic-drug substitution. Read More

Drug importers must certify that foreign manufacturers adhere to good manufacturing practices (GMP) before a product can be registered in the Philippines, according to a draft guideline. Read More

Ranbaxy’s “unprecedented” consent decree is a nightmare on a global scale for the company, but could have been avoided by being properly prepared.Read More

The world can be a scary place for devicemakers trying to keep up with ever-changing regulatory requirements in multiple countries.Read More

Since 2009, warning letter citations make clear that it’s no longer enough for devicemakers to look back at data and then react to quality problems. You are now expected to trend your quality data.Read More

Supply chain disasters happen only occasionally, but badly executed supplier agreements cause headaches every day — among them finger-pointing, misunderstandings, even lawsuits.Read More

The FDA will contract with an independent firm to study workload volume and full costs associated with reviewing biosimilars applications under proposed statutory language for a user fee program. Read More

The FDA formally closed out a Jan. 14, 2010, warning letter citing Sunrise Pharmaceuticals for manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in the batch records.Read More

The FDA’s consent decree for Ranbaxy requires third-party audits of four facilities and it can be expanded to other plants if future inspections reveal compliance or data integrity issues, making it “unprecedented in scope,” the Department of Justice says.Read More