UDI deadline extended for products with NHRIC and NDC codes

Unique Device Identifier (UDI) provision implementation is proving to be a large undertaking — a project involving many dependent tasks with multiple stakeholders including supply chain, pharmacies and payers.  “The UDI Rule, established in the Food and Drug Administration Amendments Act of 2007 (FDAAA), includes a provision that rescinds any NHRIC or NDC number assigned to a device.”  The extension to 2021 is being allowed to avoid possible disruption that could interfere with patient access to devices.  The extension was made based on feedback from industry — the guidance released on August 30th indicates that “FDA has revised the guidance to reflect the Agency’s intent not to enforce the prohibition against providing National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and device packages, with respect to finished devices that are manufactured and labeled prior to September 24, 2021.  We expect the UDI labeling requirements will be fully implemented by September 24, 2021.  We also believe additional time is appropriate for stakeholders to adopt medical device reimbursement, supply chain, and procurement systems, which do not depend on having an NHRIC or NDC number on the device label.”  Zachary Brennan reports additional information on this topic in his informative article on RAPS.

Need help ensuring your company’s UDI compliance?  Contact Pearl Pathways to start the discussion of how we can help your team.

FDA is sending a message to 15 device manufacturers

FDANews reported in a recent article that 15 new warning letters were issued to device manufacturers for GMP violations.  One letter was issued to a U.S. company with the remaining 14 issued for foreign manufacturers.  The warning letters were issued after FDA investigators conducted inspections of the manufacturing facilities and found violations.  FDA states that manufacturers should correct violations promptly and failure to correct may result in legal action.

If you need help with device manufacturing challenges, Pearl Pathways can help you achieve quality compliance in your manufacturing.  Contact us and we can make a plan together.

Common Electronic Submissions Gateway (CEGS) targeted by years’ end

Striving for greater alignment in regulatory approaches, both FDA and Health Canada are continuing work to put in place the Common Electronic Submissions Gateway (CEGS) to allow industry to submit simultaneously to both regulators.  Full functionality is expected to be completed at the end of 2016.  CEGS is one initiative of the Canada-US Regulatory Cooperation Council (RCC).  RCC also has other Joint Action Plan Initiatives in developing common monographs for routine OTC drugs and teaming up to eliminate duplicate efforts on routine surveillance of GMP inspection reports.

“Increased collaboration between regulatory agencies in Canada and the U.S. will reduce unnecessary duplicative costs for manufacturers of pharmaceutical and therapeutic products, further streamline regulatory decision-making, and minimize the delays in bringing health and personal care products to the marketplace, thereby expanding consumer choice without compromising the safety, efficacy and quality of products,”  a joint action plan for the RCC says.

For more details and links, check out Zachary Brennan’s article in RAPS.

Newly released PDUFA VI goals letter from FDA

FDA released its “goals letter”  on performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) for 2018 – 2022.  This is important news about the human drug review program — both for industry and patients.  FDA is holding a public meeting on August 15; information can be found here,  and you can register here.

Take a look at Zachary Brennan’s detailed summary in his article on RAPS.  Brennan says the “goals letter” document tells how and where the FDA spends user fees from industry.  It also communicates deadlines for upcoming guidance documents and new projects, and provides new review times for new drug applications (NDA) and biologics license applications (BLA) and more.

Preparation is key in preventing delays for obtaining orphan drug designation

Orphan Drug products give patients with rare diseases hope. The Orphan Drug Act, originated in 1983, features incentives for companies to develop drugs to treat a rare disease or condition by giving tax credits on clinical trials, eligibility for seven years of market exclusivity and no user fees.  More and more companies are jumping on this bandwagon which no doubt means a demanding number of requests for the FDA to review.  FDA continues to work on their review processes as Gayatri Rao, M.D., J.D. explains in her recent article on the FDA voice.  Her message to companies is to prepare designation requests with much attention to detail and requirements.  This preparation will minimize the number of review cycles needed with the FDA and get the therapies to the patient faster.  Call on Pearl Pathways to work with you and provide the attention to detail you require in your orphan drug designation requests.

Could FDA be made into an independent federal body?

Former FDA commissioners recently gathered at the Aspen Ideas Festival’s Spotlight Health discussing ways to minimize bureaucratic and political red tape.  FDA’s science based recommendations of safety and efficacy of food and drugs many times have political pressures and challenges to overcome.  Former regulation executives coming together to share and leveraging their many years of experience may ultimately produce a positive change.   Perhaps there could be a better path forward than the current system we have in place?  Check out Sy Mukherjee’s informative article on Fortune.

Reminder of eCTD Deadlines Approaching

A reminder that Electronic Common Technical Document (eCTD) deadlines are approaching. All submissions to the FDA including NDA, ANDA, BLA and DMFs are required to be submitted in eCTD format beginning on May 5, 2017.  IND submissions are required to be submitted in eCTD format beginning on May 5, 2018.  FDA informs that submissions that do not meet the specifications in the eCTD guidance will not be filed or received.  Paper will no longer be accepted after the dates noted.

Pearl Pathways has an experienced team to help with your regulatory submission authoring, publishing, and eCTD filings. Contact us for a value added partner to assure no interruption in your regulatory filings.

Let Pearl Pathways help with your biocompatibility concerns

Pearl Pathways invites you to look over a final guidance just released by the FDA Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”  This encourages medical device manufacturers to first start with a risk assessment to determine if new biocompatibility testing is required for premarket submissions.  It also explains new test-specific recommendations to follow.

The FDA is also holding a free webinar on July 21, 2016 discussing this final guidance. Click here for information on how you can dial-in to hear the presentation and also ask questions. Registration is not necessary.

Pearl Pathways’ experienced team is ready to assist your product development team with your biocompatibility evaluations. Contact us to be your partner in accelerating your product development regulatory pathways.

News on Compassionate Use

The FDA has been working to improve the process used by physicians to request Expanded Access — Compassionate Use to investigational drugs and biologics for their patients who need these therapies to stay alive.  In a statement released in early June from FDA Commissioner Robert Califf, M. D., the FDA released 3 guidance documents with information on Compassionate Use drugs and biologics.

The first guidance to note covers Individual Patient Expanded Access Applications – Form FDA 3926.  New Form 3926 is specifically for physicians to use to request access to investigational drugs for their patients who need these therapies to stay alive.  FDA also has instructions for completing the form.

There are 2 additional guidance documents to note that provide additional clarity on Compassionate Use. One of the guidance documents explains Compassionate Use using a Question and Answer format – click here to read.  The other guidance covers how a patient may be charged for these investigational drugs – click here to read.

Pearl Pathways’ and Pearl IRB’s experienced teams are ready to help you with this process. Expediting regulatory pathways is what we are about — contact us.

Update on OTC Drug User Fee program activity

FDA’s recent public meeting on June 10th discussing a user fee program for over-the-counter (OTC) drugs indicates new activity in this program. Expert opinion was heard at the meeting with the acknowledgement that this is a very enormous undertaking with a small staff of 18 employees to manage.  The idea is that implementing a user fee program may result in great benefits and advances in over-the-counter drugs to help us manage symptoms and conditions safely without the oversight of a doctor.

Zachary Brennan, RAPS, posted an article that has additional informative links that follow the current FDA activity on this topic.  Brennan indicates that FDA is still seeking input/perspectives from stakeholders as they work toward a more defined approach.  Help them take a first “bite” into this huge project by commenting.