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Specializing in FDA Regulatory Matters

EASeDocs

Welcome to EAS-e-Docs, a free service offering selected documents we believe can help companies comply with FDA’s laws and regulations.

In addition to this free service, EAS can locate other hard-to-find FDA documents on your behalf, for a document retrieval fee. Documents retrieved through a Freedom of Information Act (FOIA) request may incur FDA copy and research charges (at cost). For details, contact Cathryn Sacra, e-mail: csacra@easconsultinggroup.com.

February EAS-e-Docs

Drugs

D355-15: Draft Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Better the State of [insert STATE] and the U.S. Food and Drug Administration
This Memorandum of Understanding (MOU) establishes an agreement between a State and FDA regarding the distribution of inordinate amounts of compounded human drug products interstate and the appropriate investigation by the State of complaints relating to compounded human drug products distributed outside such State. This is the MOU provided for by section 503A(b)(3)(B)(i)of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)(21 U.S.C. 353a), and does not apply to drugs that are compounded by registered outsourcing facilities

D356-15: Draft Guidance for Industry: Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
This guidance is intended for entities considering whether to register with the Food and Drug Administration (FDA or Agency) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

D357-15: Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
This guidance sets forth the FDA’s policy regarding repackaging by state – licensed pharmacies, Federal facilities, and facilities that register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Actor the Act). This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(1), and where specified, section 501(a)(2)(B) of the Act, when a state – licensed pharmacy, a Federal facility, or an outsourcing facility repackages human prescription drug products.

D358-15: Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product. This guidance describes the conditions under which FDA does not intend to take action for violations of sections 351 of the PHS Act and sections 502(f)(1) and where specified, section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when a state – licensed pharmacy, a Federal facility, or an outsourcing facility dilutes, mixes or repackages certain biological products without obtaining an approved BLA.

D359-15: Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
This guidance is intended for firms that have registered with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).” This guidance explains FDA’s current thinking on adverse event reporting for outsourcing facilities.

D360-15: Complicated Urinary Tract Infections: Developing Drugs for Treatment; Guidance for Industry
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). This guidance finalizes the revised draft guidance of the same name issued on February 24, 2012.

D361-15: Alcoholism: Developing Drugs for Treatment; Draft Guidance for Industry
The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism.

D362-15: Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry
The draft guidance provides for public comment and describes draft Form FDA 3926 (Individual Patient Expanded Access–Investigational New Drug Application (IND)), which, when finalized, FDA intends to make available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational drug outside of a clinical trial for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an Investigational New Drug Application (IND) for use in cases of individual patient expanded access.

D363-15: Complicated Intra-Abdominal Infections: Developing Drugs for Treatment; Guidance for Industry
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated intra-abdominal infections (cIAIs). Specifically, this guidance addresses FDA’s current thinking regarding the overall drug development program for the treatment of cIAIs, including clinical trial designs to support approval of drugs. This guidance finalizes the draft guidance of the same name issued October 1, 2012.

D364-15: Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws; Withdrawal of Guidance
FDA is announcing the withdrawal of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws,” dated August 2010. We are taking this action because the policies stated in the guidance have been superseded by our issuance of final rules on menu and vending machine labeling. Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs; Revised Draft Guidance for Industry This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs and biologics with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. FDA is also announcing the withdrawal of the draft guidance for industry entitled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

D365-15: Abbreviated New Drug Applications and 505(b)(2) Applications
The Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

D366-15: Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff
The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.

D367-15: International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; Guidance for Industry
The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

Medical Devices

MD179-15: Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
This leap frog guidance document was developed to notify manufacturers of the recommended non-clinical and clinical studies to support a premarket approval application (PMA) for implantable MIGS devices. This draft guidance is not final nor is it in effect at this time.

MD180-15: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Mobile Medical Applications: Guidances for Industry and Food and Drug Administration Staff
FDA is issuing “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices” to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with regulatory requirements for Medical Device Data Systems (MDDS) and two similar radiology device types due to the low risk they pose to patients and the importance they play in advancing digital health. FDA is also issuing an updated version of the guidance document “Mobile Medical Applications,” originally issued on September 25, 2013, that has been edited to be consistent with the MDDS guidance document.

MD181-15: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Draft Guidance for Industry and Food and Drug Administration Staff
This guidance is intended to provide recommendations when finalized regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). This draft guidance is not final nor is it in effect at this time.