This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report

Regulatory NewsRegulatory News
| 29 July 2022 | By Ferdous Al-Faruque 

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 US Food and Drug Administration (FDA) published a guidance that describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that drug and biological product manufacturers can reference. The agency also published its first progress report on its Generic Drug Cluster and it issued a final guidance on developing clinical pharmacology studies for neonatal populations.
In its first progress report on the recently formed Generic Drug Cluster, which serves as a forum for global regulators to confidentially collaborate on generic drug development issues, the agency says that the program facilitated open discussions about an oncology treatment and a mental health treatment that may lead to faster approvals for those drugs or drugs in the same class.
FDA also published a final guidance meant to address gaps in neonatal labeling and encourage the development of therapies that are “unique to neonates.” It is tailored to sponsors developing studies for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and supplements to those applications.
In addition, FDA has published a slew of other guidances including one on the agency’s real-time oncology review (RTOR) program, how to respond to complete response letters and how FDA will update its Orange Book.
US lawmakers also either moved forward with or passed a number of bills that affect the medical industry including the Interagency Patent Coordination and Improvement Act which aims to improve information sharing between FDA, and the Patent and Trademark Office (PTO); and the Gabriella Miller Kids First Research Act 2.0 to increase funding for pediatric cancer research.
The Washington Post this week reported that the Biden administration is considering declaring the monkeypox outbreak a public health emergency and naming a White House coordinator to oversee the response. Former FDA Commissioner Scott Gottlieb has been critical of the administration’s inability to contain the virus.
Drugs & biologics
Endpoints notes that the US government contracted with Moderna for 66 million doses of its bivalent vaccine boosters for this fall, dubbed mRNA-1273.222, and that number could go up to another 234 million doses. The $1.74 billion contract is for shots that contain antigens against the BA.4/BA.5 Omicron subvariant strains that have become the dominant strains of the SARS-CoV-2 virus.
As reported by Fierce Biotech, FDA Commissioner Robert Califf supports single-arm trials for drug approvals in certain cases. The comments were made during a virtual press conference held by the Alliance for Health Policy where the commissioner said that while the pathway remains valuable for certain kinds of cancers, diseases with existing treatments should take a more "mainstream" regulatory route.
FDA released a Drug Safety Podcast to highlight increased risk of death with Copiktra (duvelisib) compared to another medicine to treat leukemia and lymphoma. The agency notes results from a clinical trial found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions and high liver enzyme levels in the blood.
Politico notes that Ferring Pharmaceuticals, which specializes in reproductive and maternal health, has hired the lobbying firm Prime Policy Group, in light of the Supreme Court’s recent decision to overturn Roe v. Wade. FDA has already been under scrutiny from conservative lawmakers for not further restricting the use of abortion medicines and there is concern from pharmaceutical manufacturers as well as those on the left that in vitro fertilization treatments might be the next target for conservative lawmakers.
Medical Devices
FDA this week published a draft guidance on labeling recommendations for Laser-Assisted In Situ Keratomileusis (LASIK) products. The agency notes it has gathered additional risk information on the procedures and wants to ensure patients are well-informed of potential side effects and alternative treatments before undergoing LASIK surgery.
Stat News notes that telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds. Of particular concern not just for the Teladoc but other in the telehealth industry is that employers are increasingly delaying or dropping contracts for virtual care.
Congress this week passed the Chips and Science Act to boost domestic semiconductor manufacturing which has especially been hard on medical device manufacturers. The move should give a leg up to US chipmakers over their Chinese competitors.
Across the pond, the lobby group MedTech Europe, which has been quieter than its US counterpart AdvaMed regarding the global chip shortage, published a call for action. According to Medtech Dive, the group wants to see: prioritized allocation of semiconductors to healthcare, now and in the future; transparency in chip allocation; greater regulatory flexibility to incorporate “varying semiconductor types” swiftly; and incentives to increase semiconductor production and allow end-users to re-design medical technologies to use newer generations of semiconductors.


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