FDA Posts

Managing CAPA Requires a Strong SOP

Mark Crawford

According to Nancy Singer and Mark Lagunowich in their informative MD+DI article entitled “Getting Your CAPA House in Order,” CAPA (Corrective and Preventative Action) remains one of the top FDA 483 citations year after year, due typically to “either inadequate processes or inconsistent adherence to processes,” they write. “This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.” (more…)

FDA Gets an Extra $10 Million for China

Mark Crawford

At the end of April the U.S. Senate approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA, including $10 million to fund an expansion of the agency’s China office. (more…)

Nanotechnology and the FDA

Nanotechnology and the FDA

Mark Crawford

In June 2011 the FDA issued draft guidance for industry entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.” Building on the recommendations within that document, the agency released two new nanotechnology-related guidances in April: (more…)

Analysis of a Warning Letter

Mark Crawford

What a difference some wording makes!

On March 6, the U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc. for false or misleading statements regarding its product AeroShot. It was told this “caffeine inhaler” could pose risk to children and adolescents and in combination with alcohol. (more…)

Mobile Is the Name of the Game (But Can the FDA Keep Up?)

Mark Crawford

According to the PricewaterhouseCoopers and the mobile operator industry association GSMA report Touching Lives through Mobile Health: Assessment of the Global Market Opportunity, global mobile health revenues could reach US$23 billion by 2017, driven by rapid growth in Europe and Asia. Monitoring services, such as those for chronic disease management, will account for 65 percent of the market, followed by diagnostic services. (more…)

Breast Implant Fiasco in France Could Have U.S. Ramifications

Mark Crawford

On February 9 European Health and Consumer Policy Commissioner John Dalli called for immediate action from the EU to ensure stringent implementation of the current legislation on medical devices. This was in response to the fraudulent use of non-medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company inFrance. The European Commission is now scrambling to tighten controls on the approval of medical devices and restore patient confidence. (more…)

New FDA Deal on Medical Device User Fees

Mark Crawford

In early February, the FDA and representatives from the medical device industry (Advanced Medical Technology Association, Medical Device Manufacturers Association, Medical Imaging and Technology Alliance) reached an agreement on recommendations for the third reauthorization of the Medical Device User Fee and Modernization Act. (more…)

The FDA Gets Moving (A Bit) on Biosimilar Guidance

Mark Crawford

On February 9 the U.S. Food and Drug Administration (FDA) released three draft guidance documents to assist biosimilar product development in the U.S.

The FDA guidance recommends a stepwise approach toward demonstrating biosimilarity that could ease trial requirements if biosimilarity can be demonstrated in earlier steps—such as a comparison between the proposed biosimilar and reference product on structure, function, animal toxicity, human pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.  (more…)

Do You Know Where Your Documents Are?

Mark Crawford

According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).

Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:

  • Unscanned paper documents
  • Confusing naming conventions
  • E-mails as documentation
  • Non-functional or non-existent SOPs
  • Missing documents

(more…)

FDA Proposes Guidelines for Improving Representation of Women in Clinical Studies

Mark Crawford

On December 19 the FDA released a new draft guidance recommending improvements to medical device manufacturers’ clinical study designs that do a better job of evaluating the effectiveness of their products for women. The draft guidance can be read at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.

Entitled “Draft Guidance for Industry and Food and Drug Administration Staff Evaluation of Sex Differences in Medical Device Clinical Studies,” the document aims to correct the historic underrepresentation of women in clinical studies. A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent women. (more…)