Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...

"Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week. The petition focuses on the labeling requirements for biosimilar products under the 2010 Patient Protection and Affordable Care Act (PPACA) , otherwise known as Obamacare. The law established for the first time an approval pathway—the 351(k) pathway—for biosimilar dr...

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...

Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson Reuters has found. Background In the US, pharmaceutical products are in general approved in one of three ways: A drug never before approved by FDA for a specific condition is approved using a New Drug Application (NDA) through the 505(b)(1) pathway A generic drug refere...

Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study . Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and crea...

A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...

US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...

Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...

Can the quality of generic drug applications to the US Food and Drug Administration (FDA) be improved, and if so, what can regulators do to improve it? So asks FDA in a new Federal Register notice published on 22 January 2014, in which the agency notes that the completeness and quality of abbreviated new drug applications (ANDA)-the application used by generic drugs-has left something to be desired by regulators as of late. Common Problems "The Office of Generic Drug...

The US Food and Drug Administration (FDA) has for years struggled with an influx of generic drug applications to the Center for Drug Evaluation and Research (CDER), resulting in a massive backlog that is only just starting to clear thanks to an influx in new user fee funding. But more than just the influx of abbreviated new drug applications (ANDAs), FDA's review resources have been stretched by the fact that many generic drug manufacturers are located outside the US, m...

The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...

The US Food and Drug Administration's (FDA) MedWatch staff had an unusually busy 6-8 September 2013 weekend, announcing the recall of products from three companies due to serious problems that could potentially affect patient safety. The Return of Recalls for McNeil One of the three companies is McNeil Consumer Healthcare, a Johnson & Johnson subsidiary that has conducted a number of high-profile recalls of many widely available products in recent years, including...