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.

New recommendations released by FDA on bioequivalence ANDA guidance

On June 29th, FDA made new recommendations on a previous draft guidance called “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The new proposals are intended to make it easier to manufacture generic popular drugs. Some of the popular drugs that the recommendations pertain to include Sovaldi, Northera, Xtandi and Olysio. These new recommendations could make it easier for manufactures to know the testing required and the standard of bioequivalence studies that need to be performed for the generic drug.

To read more on the recommendations and new guidance, continue reading on raps.org here.

NIH plans to turn around factory

The National Institute of Health (NIH) is clearly communicating that it plans to find a way to fix the deficiencies found last month at its “Pharmaceutical Development Section” by FDA. Although this is a major step back for the organization, it has already created a Remediation plan to fix the situation. This plan consists of two parts; NIH Interim Corrective Action Plan PDS and NIH Interim Corrective Action Plan Pharmacy.

NIH hopes to make all of the necessary corrections to its facility by September 2015. To find out more about the deficiencies found by FDA and NIH Remediation plan, click here.

FDA calls for generic pills to be similar to their reference drugs

Food and Drug Administration (FDA) has determined there is a safety risk if the shape and size of a generic drug is not similar to its reference drug. FDA made suggestions in a guidance last week calling for the original pill and capsules and its generic form to be similar in order to provide safety for patient use. It has been found that the size and shape of the capsule can affect the person’s ability to swallow.

To find out more on the argument of size and shape of the generic pill, click here.

Want to know about the latest FDA guidance’s? Our staff can help. Email us at contact@pearlpathways.com.

FDA informs others on REMS via new website

FDA is trying to help make it easier access information about when it is monitoring unsafe drugs throughout the United States. These controls are called REMS or Risk Evaluation and Mitigate Strategies. FDA created REMS in 2007 to guarantee the safe use of a potentially hazardous drug.

Prior to this new website launched on June 17, 2015, locating a REMS plan was via a non-user friendly database. But FDA hopes that locating REMS information will be much improved with their new website. Check it out here.

To find out more about what Alexander Gaffney, RAC says about REMS and FDA’s help to keep others informed, click here.

Want help learning more about the tracking requirements for a product subject to REMS? Our staff can help. Contact us at contact@pearlpathways.com.

FDA tries to determine which devices should be tested

FDA produced a draft guidance on whether or not medical devices are fit to be tested on humans. The guidance is called “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)”.

Per Alexander Gaffney of RAPS, the reasoning for this draft guidance is to provide “greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human study.” Many times when a medical device is being tested, the risks and benefits are discovered during the trial instead of before. This guidance was created to help ensure the assurance and risk mitigation of a medical device when used in humans.

To see what else Alexander Gaffney says about the new guidance by FDA, continue reading here.

New FDA guidance causes issues with CMC information

The US Food and Drug Administration (FDA) recently published new guidance titled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.” This guidance was created to help the industry distinguish which changes to a pharmaceutical firm’s manufacturing process must be reported to federal regulators under the Pharmaceutical Quality system.

In, Zachary Brennan’s article, he suggests the reporting mechanism is clear, but the FDA would ultimately like to resolve any confusion to alleviate any adverse impact on the industry. These impacts can include change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.

While the FDA intended to make this new guidance easier for industry professionals to recognize where to send their approvals, it still allows room for confusion.

To read Zachary Brennan’s full article click here.