This Week at FDA: Post-warning letter meetings, DSCSA update, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, FDA issued new guidances on post-warning letter meetings for generic drugmakers, DSCSA compliance, and more. The agency also published a white paper describing its prototype assessment protocol for assessing a facility’s level of quality management maturity (QMM).

On Friday, FDA published a draft guidance explaining its implementation of post-warning letter meetings for facilities that manufacture generic drugs under the Generic Drug User Fee
18 Amendments (GDUFA III) program. The 14-page guidance describes the agency’s performance goals, the new meeting type, eligibility criteria, and offers information on the meeting request package and the possible outcomes when a meeting is requested.

After offering firms a one-year reprieve from track and trace requirements under the Drug Supply Chain Security Act (DSCSA) last week, FDA issued a two final guidances this week expanding its one-year enforcement delay to wholesale distributor verification requirements and package-level security requirements.

In a white paper released earlier this week, FDA outlined its prototype assessment protocol for measuring a firm’s quality management maturity (QMM) level. The five practice areas covered by the protocol include management commitment to quality, business continuity, advanced pharmaceutical quality system (PQS), technical excellence and employee engagement and empowerment. The paper also responds to several misconceptions about QMM, including whether QMM assessments can be used to evaluate current good manufacturing practice (CGMP) compliance and whether QMM can be used to evaluate product quality – the short answer to both is no, QMM assessments cannot be used to determine CGMP compliance and are not meant to evaluate quality at the product level.

Amid heightened scrutiny of infant formula manufacturers in the wake of a bacterial outbreak that led to multiple recalls, FDA this week issued warning letters to three infant formula makers, including ByHeart, Inc., Mead Johnson Nutrition (Reckitt) and Perrigo Wisconsin, LLC. The warning letters follow recent inspections of the three firms and concern the firms’ ongoing corrective actions. “Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious,” said Donald Prater, acting director of the Center for Food Safety and Applied Nutrition.

Drugs & biologics

This week, FDA finalized guidance on developing drugs to treat nontuberculosis mycobacterial pulmonary disease caused by mycobacterium avium complex.

The Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ) published a new manual of policies and procedures (MAPP) detailing the responsibilities for assessing in vitro testing for oral drug products administered via enteral feeding tube and revised a MAPP on using four-part harmony in quality-related assessment communications that was first issued in September 2017.

FDA announced a public meeting on recommendations for its Over-the-Counter Monograph Drug User Fee (OMUFA) program that will take place on 28 September 2023.

The agency also issued warning letters to several drugmakers, including Gadal Laboratories, Inc., Cosmobeauti Laboratories & Manufacturing Inc. and K.C. Pharmaceuticals Inc.

Endpoints reports that Sen. Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) wrote to FDA Commissioner Robert Califf to request changes to how the agency maintains its Orange Book to “close loopholes” that drugmakers use to delay generic competition. The lawmakers’ recommendations include “clarifying guidelines for patents that can be listed in the Orange Book” and working with the US Patent and Trademark Office (USPTO) to review and validate patents listed in the book.

FDA has issued a complete response letter (CRL) to Outlook Therapeutics for its wet age-related macular degeneration (AMD) drug Lytenava (bevacizumab-vikg), citing manufacturing and data issues, according to Reuters.

Medtech

The Center for Devices and Radiological Health’s (CDRH) Patient Engagement Advisory Committee will meet next week to provide recommendations to the agency on advancing health equity in medical devices.

CDRH also sent a warning letter to Tesla BioHealing, Inc. over the company’s marketing of its Tesla MedBed Generator and Tesla BioHealer devices, which the agency said are adulterated and misbranded. The agency said the devices, which would be regulated under 21 CFR 890.5500 as infrared lamps, do not contain a heating element, and were marketed for different intended uses, including to treat “severe conditions” such as cancer, stroke-paralysis, and traumatic brain injury” that would preclude the devices from being exempt from premarket notification requirements.

FDA announced a Class I recall for Hamilton Medical’s HAMILTON-C1, C2, C3 and T1 ventilators due to software issues that could cause the products to stop working without notice.

The agency also provided an update on the risk of device failures with Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Baloon Pump (IABP) devices. The devices have been subject to multiple voluntary recalls, six of are Class I recalls. The agency warned health care providers that device failures “continue to be observed with Cardiosave IABP devices,” operating on both AC or battery power.

This Week at FDA: Post-warning letter meetings, DSCSA update, and more

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