Regulation

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

Orphan drug access varies across multiple markets

European countries differ in their value assessment of new orphan drugs, but steps can be taken to create a more harmonized, comparable and rational evidence-based decision-making system in Europe, two experts from the London School of Economics Health reported at the Ninth Orphan Drug Congress 2018. The presentation by Aris Angelis and Panos Kanavos covered […]

U.S. enhances malaria-fighting toolkit

In an unusual action, the U.S. Food and Drug Administration (FDA) asked an advisory committee to meet twice in two weeks this past summer to discuss nearly identical products with similar indications from two different pharmaceutical companies. During their vote, committee members noted the global need for additional agents for the prevention of malaria.   […]

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Generics companies, responding to tough times, steer towards higher-risk portfolio strategies

These are tough times financially and strategically for many generics companies, particularly in the U.S., the world’s largest pharmaceutical market. Manufacturers are experiencing falling net prices driven by customer consolidation and increasing competition, coupled with a lack of operational flexibility and a landscape of new product opportunities significantly different from those of the past. Additionally, […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]

FDA draft guidance addresses inclusion of adolescents in oncology trials

With an eye toward helping industry, investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials. Allowing adolescents in relevant trials would allow for earlier access to life-saving drugs in this […]

Regulatory considerations, strategy and best practices for choosing a quality CMO

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and […]