(571) 447-5500

The FDA recently published a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Due to the flood in the market of substandard and dangerous hand sanitizers during the COVID 19 pandemic, the FDA requested a revision to USP’s monographs for alcohol and dehydrated alcohol, which will be enforced as of 1 September 2020. The revision bulletin outlines the new quality standard for alcohol with a testing requirement for methanol contamination. The agency’s investigation of contaminated hand sanitizers is ongoing.

FDA has updated temporary policy guidances for Hand Sanitizers in effect during the COVID-19 health crisis, in order to provide additional clarification on testing of alcohol used in manufacturing according to these temporary policies. These steps were taken to help ensure that harmful levels of methanol are not present in these products. The agency provides clarification that companies test each lot of the active ingredient (ethanol or isopropyl alcohol (IPA)) for methanol if the ethanol or IPA is obtained from another source. FDA recommends using the test methods described in the USP monograph for alcohol (ethanol) and conducting the testing in a laboratory that has been previously inspected by FDA and is compliant with current good manufacturing practice. Alcohol-based hand sanitizers that are contaminated with methanol are subject to adulteration charges under the FD&C Act. Adverse event reporting guidelines and an additional denaturant formula are also included in the updated guidances.

A recent communication was sent by FDA in order to clarify the timing of the agency’s implementation of new reporting requirements for manufacturing volume data under section 3112(e) of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. As of 23 September, 2020 the FDA will be authorized to begin collecting data, although the agency does not intend to do so at the moment as their system is not yet operational. The FDA does not intend to begin this collection until it is able to do so through an electronic data submission portal. The CARES Act requires each registered drug establishment to report annually the “amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed” by the registrant for commercial distribution. As updates to this implementation are issued, EAS will keep our clients informed.

The FDA made available a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. This guidance provides answers to numerous frequently asked questions regarding drug development programs, manufacturing operations during the pandemic and the agency’s ability to conduct inspections. FDA divisions remain fully capable of continuing daily activities, while responding to needs related to the public health emergency. Questions and answers in this guidance provide information related to inspections for facilities manufacturing pharmaceutical products and sites involved in the conduct of clinical, analytical and nonclinical studies

The Final Guidance document Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products describes the conditions under which FDA generally does not intend to take action regarding required stability studies for repackaged products and the expiration date to assign under those conditions. This guidance finalizes the revised draft guidance issued in August 2017. The guidance addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA under section 510 of the Federal Food, Drug, and Cosmetic Act, and to comply with current good manufacturing practice regulations in 21 CFR parts 210 and 211.

The Inactive Ingredient Database webpage has announced updates to the Inactive Ingredient Database. Enhancements to the IID were committed to by the agency under GDUFA II. These enhancements allow users to perform electronic queries to obtain accurate maximum daily exposure (MDE) information for excipients, also referred to as maximum daily intake, for each route of administration for which data is available. The updates began in July 2020 and will continue as FDA obtains more MDE information. Additionally, the Quarterly Inactive Ingredient Change Log was updated in June 2020 to a searchable interactive format. These enhancements are intended to help industry make informed decisions about excipient selection during drug development. The IID Q & A webpage provides additional information regarding the enhancements.

The U.S. Food and Drug Administration issued an EUA Letter of Authorization – Umbrella EUA for Surgical Masks. As explained in the EUA, surgical masks that meet specific performance requirements are authorized for use in health care settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials. Manufacturers must provide test reports that demonstrate that the surgical mask meets the performance criteria in the EUA and is not excluded, in order to be added to the FDA’s Surgical Mask EUA Appendix A. The following surgical masks are excluded from the scope and are not authorized under this EUA. Surgical masks that 1) Are FDA-cleared, 2) Are manufactured in China, or 3) Include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents. If you have questions about this EUA, contact the Division of Industry and Consumer Education.

Federal Register Vol. 85, No. 149 announcing FDA 2021 GDUFA user fee rates

Fee category  Fees rates for FY 2021
Applications:
Abbreviated New Drug Application (ANDA) $196,868
Drug Master File (DMF)  $69,921
Facilities:
Active Pharmaceutical Ingredient (API)
Domestic    $41,671
API—Foreign $56,671
Finished Dosage Form (FDF)—Domestic $184,022
FDF—Foreign $199,022
Contract Manufacturing Organization
(CMO)—Domestic  $61,341
CMO—Foreign   $76,341
GDUFA Program:
Large size operation generic drug applicant $1,542,993
Medium size operation generic drug applicant  $617,197
Small business operation generic drug applicant $154,299

Federal Register Vol 85, No. 149 announcing FDA 2021 PDUFA rates.

Fee Category Fee rates for FY 2021
Application:
Requiring clinical data $2,875,842
Not requiring clinical data $1,437,921
Program $336,432

 

Federal Register Vol. 85, No. 149 announcing FDA 2021 MDUFA rates. See the Federal Register notice for details on the small business qualification.

Medical Device Fees for FY 2021

Application fee type

Standard fee (as a percent of the standard fee for a premarket application)

FY 2021 standard fee

FY 2021 small business fee

Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))

Base fee specified in statute

$365,657

$91,414

Premarket report (submitted under section 515(c)(2) of the FD&C Act)

100

365,657

91,414

Efficacy supplement (to an approved BLA under section 351 of the PHS Act)

100

365,657

91,414

Panel-track supplement

75

274,243

68,561

De novo classification request

30

109,697

27,424

180-day supplement

15

54,849

13,712

Real-time supplement

7

25,596

6,399

510(k) premarket notification submission

3.40

12,432

3,108

30-day notice

1.60

5,851

2,926

513(g) request for classification information

1.35

4,936

2,468

Annual fee for periodic reporting on a class III device

3.50

12,798

3,200

Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14))

Base fee specified in statute

5,546

5,546

Guidance Document updates on the FDA website:

All divisions

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

This guidance document is intended to describe the current thinking of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act.

Multiple Function Device Products: Policy and Considerations

Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures Act amended the Federal Food Drug, and Cosmetic Act to add section 520(o), which excludes certain software functions from the definition of device in section 201(h) of the FD&C Act.

CDER

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)

This guidance describes FDA’s compliance policy related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study

Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act

This draft guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications.

BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE

This technical conformance guide, when finalized, will represent the current thinking of the Food and Drug Administration on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

CDRH

Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway

This final guidance provides performance criteria for conventional Foley catheters in support of the Safety and Performance Based Pathway. 

Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway

This final guidance provides performance criteria for cutaneous electrodes in support of the Safety and Performance Based Pathway. 

CDER & CBER

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML).

Male Breast Cancer: Developing Drugs for Treatment

This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research for the treatment of male patients with breast cancer.

Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry

The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein (TP) by providing a systematic, risk-based approach. 

Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry

This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway).

Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans

The purpose of this guidance is to provide recommendations to sponsors regarding the submission of an initial pediatric study plan (iPSP) and any amendments to the iPSP

Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval

This guidance is intended to assist sponsors in designing trials to support marketing approval of drugs and biological products for the treatment of high-risk early-stage breast cancer in the neoadjuvant (preoperative) setting.

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format

This guidance is intended to assist applicants in complying with the content and format requirements for the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products.

Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry

This guidance describes FDA’s recommendations to investigational new drug sponsors for setting endotoxin limits during the development of investigational drugs intended for use in combination with other approved drugs or for the codevelopment of two or more investigational drugs.

Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

CBER

CPG Sec. 280.100 – Stability Requirements – Licensed In Vitro Diagnostic Products

The purpose of this Compliance Policy Guide is to provide guidance to FDA staff on stability studies for in vitro diagnostic products (IVDs) licensed by the Center for Biologics Evaluation and Research

CPG Sec. 280.110- Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood Grouping Reagents

The purpose of this Compliance Policy Guide is to provide guidance to FDA staff on the microbiological control requirements for Anti-Human Globulin (AHG) and Blood Grouping Reagents (BGR) licensed by the Center for Biologics Evaluation and Research

COVID specific FDA webpages

Personal Protective Equipment EUAs

FDA updates on hand sanitizers consumers should not use

Posted in Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices.