FDA releases new 510(k) guidance

On August 5th, the US Food and Drug Administration (FDA) released a new guidance on 510(k) submissions. This guidance is called “Refuse to Accept Policy for 510(k)s” and the plan is for it to be in effect this October.

The reason for this new guidance is to provide more of a consistent acceptance amongst 510(k) submissions. The new changes include checklists, criteria for submission, as well as criteria for alternate submissions. FDA hopes the new guidance will help make submissions smooth to submit and accept in the future.

To read Michael Mezher’s full article in RAPS, click here. Need help with your 510(k) submission, contact our experts at contact@pearlpathways.com.

Quality Metric Guidance announced by FDA

This week the US Food and Drug Administration (FDA) released its draft guidance on how to advance risk-based inspections and improve issues with drug shortages. Earlier this year, FDA created the Office of Pharmaceutical Quality (OPQ) to help look at drug product and quality level. Many drug shortages are caused by manufacturer quality issues. The creation of the new office hopes to curtail future shortages and problems.

The new draft guidance aims to not only improve the quality of drugs, but decrease the amount of inspections needed.

To read more, check out Michael Mezher’s article in RAPS here.

openFDA’s one year anniversary

It has been one year since FDA launched its initiative called ‘openFDA’. OpenFDA was an order brought by the White House to help others have access to the agency’s public data. One type of information users now have access to is FDA’s long list of application programming interfaces (APIs) such as medical device reports, approved drug labeling and many more.

FDA is hoping to spur more innovation not only throughout the agency but through the surrounding communities. Communities are the main reason that openFDA has been so successful, and FDA hopes to continue its success by involving them more through prioritizing which data the community is interested in.

To read more on Michael Mezher’s article in RAPS, click here.

FDA and Google joining forces?

The US Food and Drug Administration (FDA) and Google met last month to talk about a new ‘adverse event trending’ system.

FDA currently tracks adverse events in their FDA Adverse Event Report System (FAERS). However there are concerns that this system underreports since patient and doctor reporting to this system is voluntary. While it is mandatory for drug makers to report via FAERS, patients and doctors can as well; however, because this reporting is voluntary, many fear they are missing important adverse event trends.

Adverse reports are vital for drug safety for patients, as often is the case, not all adverse events are found during a clinical trial. To fix the underreporting problem, FDA has explored social media, search engine, and internet sources for additional information.

As reported by Michael Mezher on www.raps.org, FDA and senior leaders at Google met last month. Perhaps FDA is exploring how to collaborate with Google to develop a new system in drug-safety surveillance.

To read more, check out Michael Mezher’s article in RAPS here.

Congress officially passes the 21st Century Cares Act

On July 10th, the 21st Century Cares Act was passed which will increase the NIH and FDA funding. This increase in funds is to install a new framework for evaluating patience’s experience with drugs and to create a new national pediatrics research network and will be impacting CRO’s.

Those against this bill are worried about how the bill will be paid for and their affects of bring new cures to the market. Although the payment of the bill is not stated, many are looking forward to see how the bill will help the world.

To read more on Zachary Brennan’s article in outsourcing-pharma, click here.

What to know about FDA’s priority review vouchers

Since 2007, FDA has been issuing priority review vouchers for pharmaceutical products. In 2015 the newest priority review vouchers to focus on reducing time and cost of drug development. Developing a new drug takes a lot of time and money. In the United States, about every 1 in 10 drugs that reach the phase 1 clinical stage, get approved. Even if a drug does get approved it can take up to a year or more to receive the funding or find patients for clinical studies.

The reason for these vouchers is to spur drug development. The vouchers give a company the ability to have a drug reviewed under FDA’s priority review system. Ultimately these vouchers could lead to finding new drugs or a cure for many diseases, particularly rare or difficult to treat diseases.

To read more, check out Alexander Gaffney’s priority review vouchers article at www.raps.org and click here.

120 types of medical devices may be exempted per new FDA Guidance

On June 30th, the US Food and Drug Administration (FDA) announced the intent to exempt 120 medical device classes with the goal to make it easier for companies to market devices. These devices will be exempt from the review requirements and premarket notifications (i.e. 510(k)).

FDA regulation has three classifications for medical devices; low, moderate and high risk. Low risk medical devices have fewer costs and regulatory requirements; therefore manufacturers often desire that their products meet this category.

More details and a list of the 120 types of medical devices can be found in the new FDA guidance released July 1, 2015 entitled “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.

FDA should change the regulations to exempt this list of devices from premarket notification ultimately; however, per Alexander Gaffney’s article in www.raps.org, FDA says it won’t “enforce compliance with 510(k) requirements” in the meantime, and will not require companies to submit a 510(k).

To learn more, read Alexander Gaffney’s article on www.raps.org on FDA’s plan, and check out the new guidance here.

New FDA Program plans to focus on Autism and 7 more diseases

On July 1st, FDA announced its plans to focus on eight conditions under its Patient-Focused Drug Development (PFDD) Program in 2016-2017. Of these eight conditions, one of them is Autism, an autoimmune disorder.

The PFDD is part of the Prescription Drug User Fee Act (PDUFA) and plans include more patient feedback. These interactions include the patient’s assessment of the treatment, how the disease affects them, which treatment they prefer and more.

The eight conditions the article states consist of: alopecia, autism, hereditary angioedema (melanoma), non-tuberculosis mycobacterial infections, patients who have received an organ transplant, psoriasis, neuropathic pain associated with peripheral neuropathy and sacopenia.

To read more on Alexander Gaffney’s article on FDA’s PFDD program, continue reading here.

Pharmacies given an extension to comply with track and trace policy

On June 30th, the US Food and Drug Administration (FDA) gave pharmacies a four-month extension to comply with the track and trace policy. This track and trace policy was original created in 2013 under the Drug Quality and Security Act (DQSA). Under the DQSA, was the Drug Supply Chain Security Act (DSCSA), which establish the ‘track and trace’ policy. If drugs were being counterfeited, the policy allows FDA to find them by tracking the serial number on drugs while it moves through out the supply chain.

However, pharmacies have been having a hard time putting the track and trace system into effect because it is hard to implement the policy into their current systems.

To read more about the granted time extension and the track and trace policy, read more here.

FDA produces a new guidance on the standards for surgical gowns

After some of the most famous medical outbreaks have occurred in recent years, FDA has determined that not all surgical protective apparel is equal. FDA recently published a Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings reclassifying the levels of protection for surgical equipment. The guidance illustrates what apparel is to be concerned least protective to most protective. Not only does the guidance explain the level of protection, but it also puts the apparel (i.e. gowns) into classes, demonstrating their specific level of protection as well.

To find out more on the background of the new standards and information on the guidance, check out Alexander Gaffney’s article on raps.org here.