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Focus on Regulation

Tag Archives: FDA

To certify or not to certify? FDA has answered the question

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.  

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device identifier (UDI) compliance date for certain class I devices which are subject to current Good Manufacturing Practice (cGMP) requirements and unclassified devices.

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition

FDA: Implementation of Amended Intended Use Regulations Delayed Until March 21, 2017

On February 7, 2017, the Food and Drug Administration (FDA) delayed implementation of its January 9, 2017, final rule addressing the regulation of tobacco products as drugs, devices, or combination products.  That rule, which also amended the intended use regulations for drugs and devices, was to go into effect today, February 8, 2017; however, implementation

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On January 18, 2017, as one of the last actions of the outgoing Obama administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the “Agencies”) issued a final rule overhauling the regulations (82 Fed. Reg. 7149, Jan. 19, 2017) intended to safeguard individuals participating in research, often referred to

What’s ahead with the new Trump administration?

It’s no secret that the life sciences industry has had some challenging moments with lawmakers in recent years. And despite efforts by the White House, Congress, FDA, and other regulatory agencies, in most cases the law continues to lag behind the industry’s pace of innovation. So, how will the Trump Administration address the industry’s challenges?

FDA Strengthens Requirements for Surgical Instrumentation Used with Urogynecologic Surgical Mesh

Effective January 6, 2017, the U.S. Food and Drug Administration (FDA) reclassified surgical instrumentation for use with urogynecologic surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class I (general controls) devices to class II (special controls) devices. Surgical mesh—and the instrumentation for its administration—have been used for the transvaginal repair of POP since the

FDA Clarifies Requirements Regarding Submission of Manufacturing Establishment Information

On December 29, 2016, FDA issued a new draft guidance regarding drugs and biologics entitled “Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.” 81 FR 96013 (Dec. 29, 2016). The guidance provides an overview of the requirements for a valid electronic submission of manufacturing establishment information (MEI) under section 745(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to publicly post their expanded access (EA) policies for individual patient access. This deadline falls on February 11, 2017. For new investigational drugs, this provision applies upon initiation of a Phase II or Phase III study for that drug.

21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain

Last Wednesday, the U.S. House of Representatives passed the 21st Century Cures Act , the culmination of an extensive, multi-year effort by the House Energy and Commerce Committee to develop this sweeping legislation. The 21st Century Cures Act now faces a vote in the Senate, likely within days.  The White House has already expressed support for

New Rule Amends FDA’s Citizen Petition Regulations to Implement Section 505(q) of the Food, Drug, and Cosmetic Act

The U.S. Food and Drug Administration (FDA) has issued a final rule implementing section 505(q) of the Federal Food, Drug, and Cosmetic Act (FDCA).  Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 FR 78500 (Nov. 8, 2016). Congress enacted 505(q) with the purpose of ensuring that

Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework

On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to allow the use of observational data in manufacturers’ advertising and promotion of drugs and medical devices. The FDA is holding a public meeting  on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared

EMA and FDA set up new working group on rare diseases

On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is intended to contribute to sharing experiences and best practices on the approach of the two regulators to the development and scientific evaluation of medicines for rare

Compliance Deadlines for New ClinicalTrials.gov Requirements Explained: What Results to Post and When

As discussed in a previous client alert (here), the Department of Health and Human Services (HHS) recently issued a final rule governing the requirements for public registration of trials and posting of data to the ClinicalTrials.gov database. In a significant expansion over the previous requirements, effective January 18, 2017, responsible parties will have to publicly report the results of more clinical trials, including some for investigational drug products and devices that may never reach the marketplace.

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”  This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order

FDA Is Looking at the Money Trail: Agency Describes Potential Investigator Bias Based in Part on Industry Payments

Last week, the U.S. Food and Drug Administration (FDA) issued a briefing document in advance of a joint advisory committee meeting held on Wednesday, September 14, 2016. See FDA Briefing Document. It was a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee and was held to discuss “Serious Neuropsychiatric Adverse Events with Drugs for Smoking Cessation.” Id. See title of report. Pfizer, the manufacturer of Chantix (varenicline), a product intended to help patients quit smoking, has asked FDA to remove a box warning of potential psychiatric risks to patients, including suicide and suicidal ideation. Pfizer provided data from a post-marketing study of 8,000 subjects at 140 sites around the world that was designed to assess the real-world risk of suicidal behavior associated with the use of smoking cessation drugs to support its request that the boxed warning be removed.

Certain Antiseptic Ingredients No Longer GRAS/GRAE, Says FDA

FDA announced a final rule today determining that certain common ingredients, most notably triclosan and triclocarban, in over-the-counter consumer antiseptic washes are not generally recognized as safe and effective (GRAS/GRAE), and thus, can no longer be provisionally marketed under the OTC Drug Review. The final rule affects the status of antibacterial soaps, hand washes, and

Finally! FDA Announces Highly-Anticipated and Long-Awaited Public Hearing on “Off-Label” Communications

In a Federal Register notice published September 1, 2016, the U.S. Food and Drug Administration (FDA) announced a public hearing for November 9-10, 2016 on issues related to industry communications about unapproved uses of approved drugs, biological products and approved, cleared and exempt medical devices. FDA seeks input from a broad array of stakeholders, including

FDA Revises Its Drug Establishment Registration, Drug Listing, and National Drug Code (NDC) Regulations

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule amending its regulations governing drug establishment registration and listing requirements for U.S. and foreign firms.  Also noteworthy is that the final rule expands FDA’s regulations governing National Drug Codes (NDCs).  The final rule is available at 81 Fed. Reg. 60170 (Aug. 31, 2016)

A Renewed Focus on Quality: FDA Issues Proposed Rule Amending GLP Regulations

On August 24, 2016, FDA published a proposed rule that amends the regulations regarding good laboratory practice (GLP) under 21 CFR part 58. GLPs must be followed by nonclinical laboratory safety studies that support or are intended to support applications for research or marketing permits for products regulated by FDA, including drugs. 21 CFR 58.1(a). The proposed regulations center on changes related to data quality and multisite studies.
In December 2010, FDA published an advanced notice of proposed rulemaking (ANPRM) on these topics. More than five years later, the agency issued this proposed rule. FDA explains that the purpose of the rule is to ensure the quality and integrity of data derived from these nonclinical studies, and to integrate quality into planning, conducting, and reporting the studies.