On December 29, 2016, FDA issued a new draft guidance regarding drugs and biologics entitled “Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.” 81 FR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).
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.
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
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
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
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
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.
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,
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
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.
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
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
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)
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.
Yesterday, the U.S. Drug Enforcement Administration (DEA) took a number of actions regarding the federal control of marijuana, including denying a citizen petition to transfer the substance out of Schedule I, issuing a policy change to expand the number of entities the federal government will allow to grow marijuana for research, and concurring in a USDA statement of principles regarding industrial hemp.
Last week, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) issued joint draft guidance on responsibilities for preparing and maintaining written policies and procedures for Institutional Review Boards (IRBs). The agencies, both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, have been working together to harmonize federal regulatory requirements and guidance in this area. The draft guidance entitled “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs” (the Draft Guidance) is designed to assist IRBs and institutions responsible for the review and oversight of human research protections under both FDA (21 CFR Parts 50 and 56) and HHS regulations (45 CFR Part 46).
Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state
As they grow in popularity and functionality, mobile devices increasingly connect people virtually with the places and institutions they would otherwise visit in person. These include malls, banks, and even their own workplace. More and more, mobile devices are also connecting people with one of the places they least want to go: doctor’s offices.
On June 2, 2016, FDA issued three final Guidances for Industry—two of the three are aimed at clarifying the expanded access applications and procedures, while the third discusses charging for investigational drugs under an Investigational New Drug (IND) application.
Though the biosimilar market is still young, the number of companies working on biosimilar products is growing, putting pressure on regulators to make decisions on how they get approved—and on makers of the reference products on which they are based to ensure their intellectual property and market share are protected. Discussing these issues are Phil Katz, partner and head of Hogan Lovells’ FDA Pharmaceutical and Biotechnology group in the Washington, D.C., office; and Stephen Bennett, an IP partner in the London office.
On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student
On May 17, 2016, FDA published a Draft Guidance for Industry regarding use of electronic health records (EHRs) in clinical trials, building on previously issued guidance on computerized systems and electronic source data used in clinical investigations. As summarized below, this Draft Guidance provides a number of important recommendations to study sponsors who rely on electronic data that are generated and maintained by healthcare facilities in the routine care of patients.
Earlier today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing a topic affecting the entire pharmaceutical industry—Data Integrity. The guidance, entitled Data Integrity and Compliance with CGMP, Guidance for Industry (Draft Guidance), and styled as a series of questions and answers, is the first guidance document FDA has issued specifically concentrating
The FDA issued its final guidance for the industry on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, three years after the draft was first published.