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.

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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

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FDA produced a draft guidance on whether or not medical devices are fit to be tested on humans.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Per Alexander Gaffney of RAPS, the reasoning for this draft guidance is to provide “greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the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.

Two weeks left to register for the IMDMC workshop on June 25th

The Indiana Medical Device Manufacturers Council (IMDMC) is having an event to give those new to the medical device industry a background on FDA regulation. At the event, Pearl Pathways’ own, Gretchen Bowker COO & RAC will be presenting on, Pathways to Market. The workshop provides a chance for those to discover ­­­­­ more on the pathways for FDA regulation.

What: A workshop exploring all the perspectives of the FDA inspection process.

When: Thursday, June 25th, 2015, 8:00 AM to 4:30 PM EDT

Where: The Montage (8580 Allison Pointe Boulevard, Indianapolis, IN 46250)

Are you new to the medical device industry? Do you want to learn more about the regulation? Register here today! (Lunch will be provided.)

To learn more about the workshop and register for REG 101 & 102 Workshop, click here. We hope to see you there on June 25th!

Concerns on US FDA’s biosimilar guidance

There have been mixed reviews on the recent publishing of three final guidance’s by the US FDA. Some reviewer’s support the release of these documents, while others fear the documents led to the risk of “taking a copycat product.”

Two main groups that are concerned about these drafts are Patients for Biology Safety & Access (PBSA) and the Immune Deficiency Foundation (IDF). They believe that the guidance’s need to strengthen safety issues with biosimilar products and not focus on ‘diminishing transparency’. These two groups have sent a letter to the commissioner of FDA responding to the release of the guidance. To read quotes from the letter and learn more about the apprehensions for the guidance’s click here.

Brazils ANVISA…opposite to FDA?

When it comes to regulating agencies, the United States’ FDA is tough, yet the Brazilian ANVISA has been said to be ‘even tougher’. FDA’s main focus of regulating is on the reviewing of documentation where ANVISA spends its time focusing on the live operations and the conditions of facility. The reason that ANVISA takes this approach and doesn’t only focus on the documentation is to ensure they can witness everything. This gives the agency a chance to see what goes on in the facility on a daily basis.

ANVISA and FDA don’t only differ on the type of regulatory compliance reviews they focus on, but they differ on warning notices as well. To read more about the difference of the two agencies click here.

Want to launch into Brazil and need help? Thinking of whether to use ANVISA or FDA? Our excellent staff can help. Contact us at!

Health Canada tries to harmonize regulatory support

In 2011, the United States and Canada came together to create the US-Canada Regulatory Cooperation Council (RCC) in order to reduce economic barriers and increase regulatory support between the two countries.

Four years later, Health Canada and FDA are making efforts to continue to harmonize how both countries regulate drugs, medical devices and biological products. The two agencies are currently working on plans to synchronize the three disciplines and have already completed one plan (See their most recent plan). The two partnering countries hope their efforts increase commerce between the US and Canada, as well as improve the health care industry.

Click here to read more on the background of Health Canada and its future efforts. Need help with a Canadian regulatory filing? We can help. Contact us at .

FDA releases a new draft guidance for IND submitted by sponsor-investigators

The FDA has recently published a draft guidance entitled “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators: Guidance for Industry”, which offers an alternative to benefit non-commercial individual investigators who prepare and submit an IND. This guidance offers sponsor-investigator with step-by-step information for INDs.  “For example, protocols for Phase II and III studies should cover all aspects of the trial, including the number of subjects, inclusion and exclusion criteria, investigational methods and control groups, how the dose was determined and which procedures or tests will be used to measure the drug’s effect.”

To check out FDA’s new guidance go to:

Are you an investigator who needs help filing an IND? Our expert staff at Pearl is here to help. Contact us at