Arzezu Sarvestani from massdevice.com wrote an intriguing article on FDA’s Center for Devices and Radiological Health’s (CDRH) outlined priorities for the upcoming 2014 year. One of their main priorities will be in streamlining its clinical trial program with hopes of becoming more efficient, consistent, and predictable. To accomplish this they will have fewer applications that require multiple cycles before approval. Going along with this view the CDRH will consider moving some of the pre-data requirements to post market. FDA will soon start looking for public remarks on the framework on which pre-data requirements can be moved to post market. To read the full article click here.
Alexander Gaffney of raps.org provides a very interesting article on FDA’s move to have a more specialized program to deal with scientific advances and regulatory complexity. Gaffney introduces the article by discussing the cryptic message from FDA saying there was a need for the agency to realign the programs. When FDA announced the Program Alignment Group (PAG) they sent out a memo outlining some of the areas the PAG will focus on.
- specialization across FDA’s inspection and compliance functions based on specialization within FDA’s regulated industries and the demands of new legislation
- training that is developed collaboratively by ORA and the Centers and leads to the development of competency and training requirements to enhance and maintain FDA’s workforce
These are just a few of the focus areas provided in the article. Gaffney goes on to talk about how the PAG will impact FDA centers all over the country whether it be in the specialization of some employees or trying to “de-layer” to allow FDA to take timely and appropriate action. To determine whether this new program helps or hurts FDA, we will have to wait and see. To read the full article click here.
Alexander Gaffney of raps.org details the Food and Drug Administration’s (FDA) push for new development approaches for diabetes testing systems. FDA has typically not distinguished between prescription and non-prescription diabetes testing devices. In review of the guidance documents, it is clear that FDA wishes to address concerns regarding the potential sharing of devices, as well as cleanliness. To view Gaffney’s article, click here. To help address these concerns, FDA released two new separate draft guidances on January 6, 2014. To see both guidance documents, see the links below:
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
- Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
All comments are due April 6, 2014. Need help with your diabetes testing device or diagnostic, contact us at firstname.lastname@example.org.
Alexander Gaffney of raps.org details that the US Food and Drug Administration (FDA) is ready to launch a new work group, the Program Alignment Group (PAG). The goal in creating PAG is to streamline efforts from various organizations and centers of FDA to avoid duplication, reduce complexity, and increase globalization efforts. There are six core initial areas that the PAG will begin to focus on that deal with specialization, training, new work planning, compliance policies, lab optimization, and center/ ORA practices. FDA commissioner, Margaret Hamburg says it will take time and resources for the PAG to become a fully functioning group, but it has her full support. To read the full article, click here.
FDA final guidance entitled “Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring,” was issued early August and is similar to the draft guidance published in 2011. FDA encourages risk based remote monitoring, electronic tracking methods, and also defines that if a CRO is responsible for monitoring a study, the Sponsor should still review the CRO to ensure they are meeting regulatory and contract requirements. Zachary Brenna from outsourcingpharma.com notes in a recent article that this approach may be most appropriate for Phase II and IV trials, and, reviews some of the rationale as to why Sponsors may be slow to adopt this with pivotal registration trials. To view Brenna’s article, click here and to read FDA’s final guidance, click here. Need assistance with your clinical trial? Contact us at email@example.com for assistance with IRB reviews, protocol writing, development and execution of risk based monitoring plans, CRO audits, and more.
In 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA, Public Law 112-144) into law. This Act has several important provisions that expand FDA’s authorities and strengthens the agency’s ability to advance and safeguard public health.
Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated and not acceptable for sale in the US any drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” (1)
On July 14, 2013, a draft guidance implementing penalties for manufacturers who delay inspections or deny access to inspectors was issued by FDA. (2) The guidance defines the types of actions the FDA will consider to be “delaying, denying, or limiting inspection, or refusing to permit entry or inspection”. These include:
- Delay of inspections (i.e., delay scheduling pre-announced inspections, delay during an inspection and/or delay producing records);
- Denial of inspection;
- Limiting of inspection; (i.e., limiting access to facilities and/or manufacturing processes, limiting photography, limiting access to or copying of records, limiting or preventing collection of samples); and
- Refusal to permit entry or inspection. (2)
An additional authority provided by FDASIA is section 709. Section 709 amends section 304(g) of the FD&C Act (21 U.S.C. 334(g)) to provide FDA with administrative detention authority with respect to drugs. Section 304(g) of the FD&C Act, as amended by FDASIA, provides FDA the same authority to detain drugs that section 304(g) already provides FDA regarding tobacco products and devices.
Protecting the global drug supply chain and making sure that patients have access to the drugs they need is a priority for FDA. As nearly 40% of finished drugs are imported and nearly 80% of active ingredients come from overseas sources,(3)it is important that FDA is provided the additional tools it has been seeking to better meet the challenges of regulating a global supply chain. FDASIA is an important regulatory development that enables FDA to better regulate the safety of the drug supply and to combat the trade of counterfeit and adulterated drugs.
Need help navigating FDA inspection or issues with API vendor management? Contact us at firstname.lastname@example.org.
- Food and Drug Administration Safety and Innovation Act Section 707. http://www.gpo.gov/fdsys/pkg/FR-2013-07-15/html/2013-16841.htm. Accessed 12 August 2013.
- Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf. Accessed 12 August 2013.
- Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm357783.htm. Accessed 12 August 2013.
Forbes.com Matthew Herper describes the distorted image of the director of the FDA’s Oncology and Hematology Products, Dr. Richard Pazdur, as the villain to cancer treatments by his critics. In an interview he gave at the annual American Society of Clinical Oncology, the portrayal shifted to his reality, his standards, and pushes to bring cancer therapies to the public. Pazdur commented about the rising amounts of cancer drugs approved, “We don’t have a lot of questions on drugs because they’re slam dunks. It’s not if we’re going to approve them. It’s how fast we’re going to approve them.” Quick approvals are also being aided by a new “breakthrough” designation, which was spurred by the FDA Safety and Innovation Act of 2012. The new breakthrough designation applies to treatments for life threatening diseases such as various forms of cancer. The breakthrough designation is different than some of the other accelerated process designations because it allows the companies to call in more times and get a clear schedule to work with the FDA. Pazdur claims that there must be a difference in communication level for the entities that receive the breakthrough status, otherwise it is worthless. For the full article click here.
Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA. On July 25, 2013, Pearl Pathways’ own Gretchen Bowker will lead a webinar on FDA audits discussing the best practices and provide practical tips to prepare for FDA audits, as well as client audits. The webinar will be held through CompliaceOnline.com.
When: July 25, 2013
Duration: 60 minutes
For more information and registration click here.
Christopher Kelly reports on FDA.gov that The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. A motivating factor behind the action was the 6th annual International Internet Week of Action (IIWA), a global combative against the online sale and distribution of illegal and counterfeit medicines. One piece of this year’s campaign was Operation Pangea VI, which used the FDA’s Office of Criminal Investigations partnering with the US District Attorney’s Office to seize and shut down almost 1,700 illegal online operations. The effort running from June 18 to June 25, 2013 targeted illegal sites using large brand names and “FDA approved” labels to sell non approved drugs that look similar to Avandaryl, Celebrex, Viagra, Levitra, and Clozaril. The aim of this effort is the protection of citizens against illegal medical products. How much emphasis do you think the FDA should put into this initiative? For the full article, click here.
FierceMedicalDevices’ Damian Garde shares that the amount of medical device inspections under President Obama’s terms has skyrocketed up 47%, hitting eight year highs. The number of warning letters handed out by the FDA is correlated with this growing number as well. The growing rate of inspections and warning letters does not seem to be slowing; the agency is requesting $870 million to run the Center for Devices and Radiological Health next fiscal year. It is also clear that the agency is targeting manufacturing processes, making up 60% of the warning letters handed out. While the rest was split between design, management, and document control. How large of a role do you think the FDA should play in inspections? Read the full article here.