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Gottlieb wants industry to embrace new R&D initiatives

Earlier this month, Scott Gottlieb, announced that he will be stepping down from his post as FDA Commissioner to spend more time with his family. Although he has had a relatively short term, serving since May 2017, Gottlieb has been praised for the work he has done to modernize R&D processes and streamline guidelines for [...]

By | 2019-03-19T05:40:56+00:00 March 19th, 2019|FDA|Comments Off on Gottlieb wants industry to embrace new R&D initiatives

New FDA ‘Request to Connect’ portal goes live

Last week, the FDA launched its new ‘Request to Connect’ portal, an initiative developed by the agency to encourage greater understanding of, and participation in, the FDA's regulatory work. The online portal invites patients, their support groups, advocates and caregivers, and health care professionals and organizations to submit questions about drugs and medical devices and/or [...]

By | 2019-03-15T05:50:32+00:00 March 14th, 2019|FDA|Comments Off on New FDA ‘Request to Connect’ portal goes live

New infographics highlight success of Orphan Drug Act

The Orphan Drug Act (ODA), which was passed in 1983 to incentivize drug development for rare diseases, has come under scrutiny in recent years. There are some within industry who claim that the program has been manipulated by drug manufacturers to maximize profits and protect niche markets for treatments for more common conditions. However, advocates in [...]

By | 2019-03-08T06:33:37+00:00 March 8th, 2019|Drug Manufacturers, Health, Legislation|Comments Off on New infographics highlight success of Orphan Drug Act

FDA receives comments on its RWE regulatory framework

The FDA has recognized the important role that real-world evidence (RWE), i.e. evidence that is collected outside the tightly controlled clinical trial setting, can play in furthering drug development and facilitating drug approvals. In line with this, late last year, the FDA released a 40-page regulatory framework outlining how the agency plans to utilize RWE [...]

By | 2019-03-01T05:32:28+00:00 March 1st, 2019|FDA, Legislation|Comments Off on FDA receives comments on its RWE regulatory framework

FDA releases draft guidance on Competitive Generic Therapies designation

Since taking office in 2017, FDA Commissioner, Scott Gottlieb, has been working on developing policies to reduce barriers to generic development and to accelerate the review of new generic drug applications. Gottlieb recognizes the important role generic drugs can play in lowering drug prices in the US, and he is committed to promoting increased market [...]

By | 2019-02-19T11:33:42+00:00 February 19th, 2019|Reference Listed Drug|Comments Off on FDA releases draft guidance on Competitive Generic Therapies designation

FDA Launches new pilot project program to track and trace the drug supply chain in the US

As required under the Drug Supply Chain Security Act (DSCSA), the FDA has recently launched a new pilot project program to track and trace the drug supply chain in the US. The DSCSA, which was enacted by Congress in 2013, aims to better protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. Under this [...]

By | 2019-02-13T07:10:36+00:00 February 13th, 2019|FDA|Comments Off on FDA Launches new pilot project program to track and trace the drug supply chain in the US

FDA’s Project Facilitate, proposed initiative aims to improve current expanded access framework

The FDA is planning to launch a new program later this year which will streamline the expanded access application and review processes, so that patients can more readily receive access to promising investigational therapies. The program, which has been dubbed Project Facilitate, will see the FDA taking on a more involved role, helping drive the [...]

By | 2019-01-28T05:34:08+00:00 January 28th, 2019|Expanded Access Programs, FDA|Comments Off on FDA’s Project Facilitate, proposed initiative aims to improve current expanded access framework

FDA releases new strategic Framework for its Real World Evidence Program

Real World Data (RWD) is health data collected from outside the tightly controlled clinical trial setting. It provides greater insight into experiences with pharmaceutical products and devices at all stages, from research and development, to testing and regulatory review, right through to commercialization and market use. This raw data can be collected from a variety [...]

By | 2018-12-14T10:17:32+00:00 December 14th, 2018|FDA|Comments Off on FDA releases new strategic Framework for its Real World Evidence Program

FDA releases information on Right to Try on its website

The goal of the FDA is to ensure that patients can access needed medicines in a safe and compliant manner, and the agency will support any legislation that aims to further this. As such, although the FDA was opposed to Right to Try prior to its passage earlier this year, now that it has been signed [...]

By | 2018-12-05T08:36:22+00:00 December 5th, 2018|Expanded Access Programs, FDA, Legislation|Comments Off on FDA releases information on Right to Try on its website

Why might companies refuse to provide pre-approval drug access

After Right to Try legislation was passed in the US earlier this year, many believe that desperate patients will now find it easier to try investigational products outside of the clinical trial setting. However, like with the FDA’s Expanded Access Program, the Right to Try law does not require companies to provide their unapproved drugs [...]

By | 2018-11-30T05:11:46+00:00 November 30th, 2018|Expanded Access Programs, Legislation|Comments Off on Why might companies refuse to provide pre-approval drug access