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.

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.

Bill passed Senate that would add the Zika virus to FDA’s list for priority review vouchers

Last week, the US Senate added the Zika Virus to the priority review voucher (PRV) program for FDA.  It could be the 22nd tropical disease on the list if the bill passes in the House which seems likely. Zachery Brennan published a comprehensive article on this topic which shares a good history on the program.

While the Senate and Congress seem to be big fans of the PRV program, not all industry experts completely support this program which gives corporations who apply and earn the vouchers the ability to cut the FDA review period from 10 months to 6 months, or, they can sell them for hundreds of millions of dollars on the market.  FDA’s established opposition to the program is reviewed in an article earlier this month on www.raps.org .

Need help navigating which rare, neglected, and tropical diseases are eligible for PRVs?  Contact our staff, we can help.

Woodcock communicates 2015 CDER accomplishments & reveals top priorities for 2016

According to Zachary Brennan of Regulatory Affairs Professionals Society (RAPS), at the recent December FDA/CMS Summit in Washington, DC, Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of 2015 accomplishments and gave a look forward at priorities for 2016.

Accomplishments include 42 new drug approvals, reduction in multiple cycle reviews for generic drugs as companies understand more what they need to provide in applications, new agreements made working with the International Conference on Harmonisation (ICH) on global standards for drugs …and more.

Looking to 2016, the CDER is expected to source talent to fill positions from 680 staff vacancies, negotiate user fee agreements for prescription drug, generic drug and biosimilars … and more.

To view the CDER 2015 accomplishments and 2016 priorities, visit Brennan’s article here.  Pearl Pathways is very excited to help you expedite your 2016 life science product development pathways in the New Year.  Please contact us.

FDA releases best practices drug development draft guidance

Melissa Fassbender, inPharma, recently published an article about the US Food and Drug Administration (FDA) and the new draft guidance on best practices for drug development. Stephen King, FDA spokesman, stated that the guidance’s purpose “is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effect drugs to the American people.” The guidance, being finalized in 18 months, will act as nonbinding recommendations.

To read Fassbender’s article, click here. To submit comments to FDA regarding this draft guidance, see this link.

FDA developing regulations for NGS

The US Food and Drug Administration (FDA) is planning to develop ways to better determine accuracy of predictions from regulatory testing of next-generation sequencing (NGS), according to FDA Commissioner nominee Robert Califf.

Michael Mezher states that FDA has been working on this development as part of the Obama Administration’s Precision Medicine Initiative. FDA is considering multiple approaches, such as a flexible design concept approach and a performance standards approach.

Up next, FDA will be hosting two workshops in the first quarter of 2016 to discuss further the plan and retrieve insight from the public. To read Mezher’s article on raps.org, click here. For more information about the November workshop held by FDA, click here. Need help with your regulatory path for your NGS diagnostic? Contact us.

FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.

To read Mehzer’s article, click here. Need assistance in managing your orphan drug designation or regulatory filing? Contact us.

CDRH increases foreign inspections as planned

The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013 to 2014. The increase in foreign inspections provides evidence that the center’s efforts have been working, according to Zachary Brennan, RAPS.

Currently, Chinese manufacturers are requiring more inspections, with Germany and Japan following suit. Although inspections increased abroad, the result of warning levels decreased. The chart below demonstrates the outcomes from domestic inspections compared to foreign inspections.

inspection outcomes

To read Brennan’s article on raps.org, click here.

FDA to exempt genetic screening systems

FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be included in the exemption.

According to Zachary Brennan, “FDA may exempt a device if the agency determines that a 510(k) application is not necessary to provide reasonable assurance of the safety and effectiveness of a device.” Currently, the screening is only able to determine carriers of the genes, which have caused false positive results and unnecessary psychological distress.

FDA will make its final decision within the next 120 days. For the FDA report, click here. To find out more, visit the article.