Archives: Other FDA Developments

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Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs … Continue Reading

FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions … Continue Reading

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products. What is a biosimilar product? Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. … Continue Reading

FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks.  The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable … Continue Reading

FDA to Hold Medical Device Cybersecurity Workshop (Jan 20-21)

As discussed on our sister Life Sciences Legal Update blog, the FDA is holding a public two-day workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” on January 20-21, 2016. The FDA seeks to bring together diverse stakeholders to highlight past collaborative efforts, identify tools to aid stakeholders in implementing disclosure and vulnerability management, … Continue Reading

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars. … Continue Reading

FDA Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

As discussed on our Life Sciences Legal Update blog, the FDA has released draft guidance clarifying its acceptance of medical device clinical data from studies conducted outside of the United States. The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations to … Continue Reading

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include: (1) identifying areas of similarity between … Continue Reading

FDA to Host Clinical Outcome Assessments Public Workshop (April 1)

On April 1, 2015, the FDA is hosting a workshop entitled “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges.” The workshop will update the public on ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs. The workshop will also … Continue Reading

Happy New Year! FDA Helps Industry Ring in New Year with Generous DSCSA Compliance Policy

This post was written by Kevin M. Madagan. Time to pop the bubbly a little early! FDA announced today that the Drug Supply Chain Security Act (DSCSA) deadline of January 1, 2015 for product tracing (i.e., the new federal pedigree standards) will not be enforced until May 1, 2015. This means manufacturers, wholesale distributors, and repackagers have … Continue Reading

FDA Releases Two Draft Guidance Documents on Proposed Laboratory Developed Test (LDT) Regulatory Oversight

This post was written by Jennifer Pike and Vicki Morris. On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new regulatory oversight framework for LDTs, which are defined by the FDA as "a type of in vitro diagnostic test that is designed, manufactured … Continue Reading

FDA Releases “Purple Book,” Including Biosimilar Products

The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to … Continue Reading

FDA Releases Final Medical Device Cybersecurity Guidance, Schedules Workshop on Topic

Yesterday the FDA issued final guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which includes recommendations for medical device manufacturers on cybersecurity management and information that should be included in a pre-market submission. The recommendations are intended to supplement previous FDA guidances, “Guidance for the Content of Premarket Submissions for Software … Continue Reading

FDA Seeks Comments to Updated Guidance on Informed Consent in Clinical Trials

This post was written by Jennifer Pike and Vicki Morris. Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page “Informed Consent Information Sheet” that provides guidance for institutional review boards (IRBs), clinical investigators, and clinical trial sponsors on complying with the Agency’s informed consent regulations. Once finalized, the draft guidance will … Continue Reading

FDA Meeting on Biomarker Development (Sept. 5)

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- … Continue Reading

FDA Will Not Enforce Compliance for Mobile Device Data Systems and Other Low Risk Devices, Agency Reports

In a new draft guidance document, the Food and Drug Administration (FDA) has announced that it does not intend to enforce compliance with general regulatory controls that apply to Medical Device Data Systems (MDDS), medical image storage devices and medical image communications devices. MDDS refers to hardware and software that transfers, stores, converts format and … Continue Reading

FDA Releases Drug/Device Industry Social Media Guidance Documents

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs and medical devices may: (1) communicate both benefit and risk information on Internet/social media platforms with character space limitations, and (2) correct independent third-party misinformation about a firm’s products.  For details, see Reed Smith’s Client … Continue Reading

FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product – Comment Opportunity

This post was written by Jillian W. Riley. On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug … Continue Reading

Expedited Drug Development and Review: New FDA Resource Now Available

This post was written by Jennifer Pike. A new guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” is now available from the Food and Drug Administration (FDA). The 40-page guidance is intended to serve as a single resource for information on FDA’s policies and procedures related to its four expedited drug development and … Continue Reading

FDA Workshop to Focus on 3-D Printing of Medical Devices

According to the Food and Drug Administration (FDA), additive manufacturing, also known as 3-D printing, is entering mainstream use in medical devices, both as an alternative device production method for traditional components and as a method to create patient-matched devices. FDA has begun to receive submissions using additive manufacturing for medical devices, and the agency … Continue Reading

Busy Week for FDA’s Center for Devices and Radiological Health

This post was written by Jillian W. Riley. Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product. The … Continue Reading

Drug Companies are Reminded – FDA is Following Facebook

Our Life Sciences Legal Update blog reports today that the FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page, suggesting that consumers talk to their doctor about a drug without disclosing the risks associated with the product (risks serious enough to require a boxed … Continue Reading
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