In order to facilitate timely access to high quality, affordable generic medicines, the FDA has implemented two drug program enhancements with the goal of improving communication during the review cycle of an original abbreviated new drug application (ADNA): Discipline Review Letters (DRL) and Information Requests (IR). The FDA explains in their recently published draft guidance, entitled Information Requests and Discipline Review Letters Under Generic Drug User Fee Amendments (GDUFA), how they intend to deploy these programs.
Even though 2016 was an unusually slow year for FDA drug approvals, in 2017 the number of new drugs sent to market more than doubled. Forty-six drugs, to be precise, passed FDA approval hitting a 21 year high.
Pictured: A 3D rendering of Factor VII, one of the proteins that causes blood to clot in the coagulation cascade.
In 2007, a new law was passed that gave the FDA new authorities and responsibilities to enhance drug safety. It's called the Food and Drug Administration Amendments Act and one of its provisions gave the FDA the authority to require a Risk Evaluation and Mitigation Strategy, also called REMS, from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
In the US, there are registration and listing requirements for new drugs going into clinical trials and the companies that manufacture these drugs. Do you know if these requirements apply to your company and new investigational drug? To find you, you may look into the Code of Federal Regulations (the CFR) and in the Guidance for Industry that the FDA has made publicly available. But these on-line resources are very exhaustive, content rich and extremely detailed.
On December 7th ClinSmart hosted a Biotech/ Life Science Community Fundraiser at our HQ in Newtown, Pennsylvania (USA). This was a follow-up to a similar event hosted in August – both were a great success! A big thank you to everyone who came out, sent in donations, or helped spread the word.
Each biotech company has a different culture, communication style, set of preferences, and documentation needs, so there is essentially no single best communication method between the FDA and your IND sponsor. However, there are best practices to optimize interactions between the two entities during the drug development process to help minimize wasteful expenditures of time and resources.
If you are a small business working with the FDA to get a drug or medical device on the market, you are aware of the scrutiny of clinical trial design and data to ensure the safety of your product. But the FDA is responsible for monitoring a product’s safety after it has reached the market as well. The method that has proved most valuable in this surveillance is the implementation of MedWatch, a digital network for reporting important safety information about FDA regulated drugs, medical devices and dietary supplements.
The integrity and safety of a clinical trial greatly depends on adherence to the carefully considered and approved administration protocol for a new investigational drug. Medication errors rarely are the fault of the individual, yet are a consequence of inappropriate naming and labeling of new drugs. Specifically, it has been shown that eliminating look-alike and sound-alike names and removing ambiguous naming conventions greatly decreased medication errors. Historically, design issues with new drug products were not identified and resolved until post marketing surveillance activities or in some cases, when medication errors reached and harmed patients. So now, the FDA is driving the implementation of well-defined naming and labelling strategies that can be used by the companies before the product gets in the hand of the user.
The immense amount of information on the FDA website is overwhelming even to the most seasoned regulatory professional. Yet, start-up and small biotech companies need to have some degree of familiarity with the organization’s processes and databases as they move their product forward onto the market. To aid in this endeavor, we have carefully chosen and briefly described some useful websites, search engines and tools that you may utilize to help you navigate the complex system of the FDA.