This Week at FDA: A glut of guidances

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, the FDA went on a guidance publishing spree, announced several upcoming public meetings, and is expected to greenlight the latest COVID-19 booster vaccine.

The Center for Devices and Radiological Health (CDRH) proposed three new guidances this week aimed at modernizing its premarket notification program, more commonly known as the 510(k) pathway. The guidances propose best practices when selecting a predicate device in a 510(k) submission, situations when clinical data may be necessary, and the kinds of evidence the agency expects to see for 510(k) implanted devices.

The device center also published a final guidance on how sponsors can conform to the International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," when submitting a premarket application. It addresses several biocompatibility issues that sponsors should consider, including what risk-based approaches should be used to determine if biocompatibility testing is needed.

The Center for Drug Evaluation and Research (CDER) published a draft guidance on clinical pharmacology considerations when developing peptide drug products. It touches on issues to consider when developing such drugs, including hepatic impairment, drug-drug interactions, and safety and efficacy considerations. The center also finalized a guidance for sponsors developing drugs to treat nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC), and published a draft guidance for sponsors developing drugs to treat endogenous Cushing’s syndrome where surgery isn't an option or hasn't been effective.

FDA also finalized a guidance that addresses certain factors and procedures that institutional review boards (IRB) and clinical investigators should consider as they review individual patient expanded access submissions. Most importantly, the guidance expounds on the agency's expectations when a single member of the IRB conducts the review.

As mandated by the Drug Supply Chain Security Act (DSCSA), FDA finalized a guidance that lists standards that allow drug suppliers to securely exchange electronic data and allow interoperability between different parties and products that are part of the supply chain.

FDA also published a draft guidance on how it plans to conduct post-warning letter meetings based on its agreement with industry under the Generic Drug User Fee Amendments (GDUFA III). The meetings are meant to help companies respond to deficiencies that FDA inspectors identify at manufacturing facilities.

Finally, FDA announced it is updating and renaming a COVID-19 facemask guidance that was first implemented during the public health emergency (PHE). The agency has kept its enforcement discretion policy in place, but the new guidance reflects the updated timeline the agency has set to transition many of the products back to traditionally marketed products.

FDA has also announced several upcoming meetings, including a 9 November in-person public meeting to discuss endpoint and trial designs when developing kidney transplantation drugs. While currently approved drugs have worked very well, the agency noted that they have long-term side effects that might be alleviated with newer drugs.

On 17 November, FDA is convening a virtual meeting of its Pulmonary-Allergy Drugs Advisory Committee to discuss Merck Sharp & Dohme's gefapixant oral tablets to treat refractory or unexplained chronic cough. It will also virtually host a public meeting of its Cellular, Tissue, and Gene Therapies Advisory Committee on 31 October to discuss Vertex Pharmaceuticals' exagamglogene autotemcel (exa-cel) to treat patients 12 years and older with sickle cell disease and recurrent vaso-occlusive crises.

FDA, and the Centers for Disease Control and Prevention (CDC) are investigating reports of a tuberculosis (TB) outbreak caused by Mycobacterium tuberculosis (Mtb) that may be linked to a bone matrix product. The agency issued a safety communication about the outbreak with advice on how to mitigate the risks and resources for those potentially affected.

Drugs & Biologics

According to NBC News, FDA is expected to greenlight Moderna’s and Pfizer's COVID-19 boosters that target the currently dominant XBB.1.5 omicron subvariant as early as 8 September. At press time, the agency has not made the announcement. The news also comes just days before CDC’s Advisory Committee on Immunization Practices is expected to make recommendations on use of the boosters.

Earlier in the week, Biospace reported that according to Moderna, their latest booster also showed to be effective against the less dominant BA.2.86, EG.5 and FL.1.5.1 variants, which have alarmed public health experts because of how highly mutated they are.

The Pink Sheet reported that abbreviated new drug application (ANDA) submissions for this fiscal year have been lagging. It noted that if the trend continues, FY2023 may register the second-fewest number of ANDA submissions from generic drug sponsors since the GDUFA program began.

Medtech

Medtronic is being sued for allegedly sharing a “treasure trove of personal data” from their InPen diabetes management system with companies such as Google without patient consent, according to Medtech Dive. The lawsuit alleges that Medtronic's use of tracking tools violates the Health Insurance Portability and Accountability Act (HIPAA).

On the topic of patient data, Reuters reported that IBM is notifying Janssen CarePath customers that a data breach of their platform means there has been unauthorized access to their personal information. The company did not disclose how many people were affected but said that Social Security numbers and financial account information were not accessed in the incident.

Reuters also reported that Dutch multi-national medtech giant Phillips has reached a settlement in a US class action lawsuit related to its recent major recall of sleep apnea machines and ventilators. The company is initially expected to pay out $479M as part of the settlement.

This Week at FDA: A glut of guidances

Related topics

Recommended content

Welcome to the new RAPS Digital Experience