Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...

As pharmaceutical and biotech company stocks saw a quick rise in share prices yesterday, investors seem to believe the incoming Donald Trump administration and the avoidance of a California ballot measure on drug pricing will have a positive impact on the sector as a whole, at least financially. But while Trump has called for a reduction of federal regulations in general, it remains to be seen how he will deal with the US Food and Drug Administration (FDA). Steven Gros...

The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA. FDA’s inspection of the Sao Paulo-based manufacturing facility from 11 April to 15 April found the company: failed to approve or reject all procedures or specifications impacting the identity,...

With the restoration of diplomatic relations betweeen the US and Cuba in late 2014, the island is prepping for a wave of new and generic US pharmaceuticals and biologics, the head of the Havana-based regulatory agency, known as the Center for State Control of Drugs, Medical Devices (CECMED), told  Focus  in an exclusive interview. Rafael Pérez Cristiá, director general of CECMED, who oversees 300 staffers, said that as relations between the two countries continue to no...

After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with. The new rule, expected to take effect in 90 days, includes amendments that reorganize, modify and clarify FDA regulations on who must register establishments and list human d...

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...

As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations. The text of the proposal discusses some of the high-level themes of what both sides would to like find more common ground on, including the convergence of technical and clinical requirements applicable to devices; removing...

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue. Emer Cooke, head of international affairs at the EMA, said that the Brexit decision, which may cause the agency to leave London, “is a decision that affects a lot of the staff of the agency, p...

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and  in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China’s Anti-Corruption Agency Criticizes CFDA Over Regulatory Loopholes An inspection of China Food and Drug Administration (CFDA) by the country’s anti-corruption agency has led to the publication of a litany of alleged failings at the regulator. The graft group is calling for CFDA to standardize its review, approval and inspection processes to eliminate the “many loopho...

The EU late Wednesday finally reached an agreement on updates to the overarching regulations for medical devices and in vitro diagnostics that haven’t been updated since the 1990s. The agreed to draft regulations, the texts of which were not released, are expected to ensure that medical devices and in vitro diagnostics are safe and that patients can benefit from them in a timely manner. The political agreement between the Netherlands presidency of the European Counc...