Drugs
A study by University of Maryland School of Business risk management expert Clifford Rossi, funded by FDA and HHS, has identified a combination of factors that he says makes pharmaceutical production in the U.S. more attractive now than investing in either China or India. Rossi says that adopting advanced
Drugs
FDA has revised four guidance documents based on a final rule on the medical device de novo classification process. For example, the guidance Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff provides further detail about the types of information FDA believes are
Drugs
AstraZeneca is asking FDA for an emergency use authorization (EUA) for its AZD7442 long-acting antibody (LAAB) combination for prophylaxis of symptomatic Covid-19. The company says that if FDA approves the EUA, it would be the first LAAB to receive an EUA for Covid-19 prevention. The AZ statement
Drugs
FDA says the Covid-19 pandemic has reinforced the need to adopt and accelerate the implementation of ways to increase critical supplies and supply chain resilience. An online Advanced Manufacturing update says advanced and smart manufacturing technologies have been identified as potential ways to meet the needs. The update cites
Drugs
Recent appeals court decisions against FDA in orphan drug cases will “force FDA to take a hard look at this approach to orphan drug designations, as it may find it difficult to develop a consistent rubric for evaluating orphan drug designation requests.” That’s the view of attorneys Sara Koblitz
Drugs
Three generic drug makers — Taro Pharmaceuticals, Sandoz and Apotex —have agreed to pay $447 million to resolve alleged False Claims Act violations related to price fixing conspiracies involving various generic drugs. The Justice Department alleges that between 2013 and 2015, the companies paid and received compensation prohibited by the Anti-
Drugs
Teva Pharmaceuticals has temporarily stopped production at its Irvine, CA manufacturing facility after a recent FDA inspection cited manufacturing concerns and the company recalled 2.5 million vials of drugs that may not be sterile. The drug vials recalled include those for treating cancer, arthritis, schizophrenia and a muscle relaxer
Drugs
Merck plans to submit soon an application seeking emergency use authorization (EUA) for molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine that new data show significantly reduced the risk of hospitalization or death in Covid-19 patients. Merck and developmental partner Ridgeback Biotherapeutics just announced data from a
Drugs
Bayer has recalled all unexpired Lotrimin AF and Tinactin spray products (lot numbers beginning with TN, CV or NAA) due to the presence of benzene in some samples of the products. Benzene is not an ingredient in any of Bayer Consumer Health products, according to a recall notice. “Benzene is
Drugs
CDER drug safety operations (DSO) associate director Terry Toigo is retiring 9/30 and, in the interim, DSO senior staff member Amy Ramanadham has been named acting associate director. Ramanadham joined DSO in 2012 after completing a doctoral degree in pharmacy at the University of Maryland, School of Pharmacy. She
Drugs
The 11th Circuit Court of Appeals has overturned a Florida federal court decision granting summary judgment to FDA and Jacobus Pharmaceutical and dismissing Catalyst Pharmaceuticals’ case involving orphan drug exclusivity for its Firdapse (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS). Catalyst had challenged FDA’s approval of Jacobus’ Ruzurgi
Drugs
Reps. David McKiney (R-WV) and Abigail Spanberger (D-VA) have introduced the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE Act) to create an emergency supply of ingredients used in the manufacturing of vital generic medicines and to incentivize domestic manufacturing of these ingredients.
Drugs
Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic atrophy (GA) secondary to age-related macular degeneration, in the first half of 2022 after announcing data from the Phase 3 DERBY and OAKS studies. GA is a leading cause of blindness that
Drugs
PharmaTher Holdings has retained former CDER Division of Psychiatry Products director Thomas Laughren, who retired in 2012, as a regulatory affairs advisor. The company says Laughren will advise on regulatory matters involving KetaBet, its patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for
Drugs
FDA has approved AbbVie’s Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The company says Qulipta is the only oral calcitonin gene-related peptide receptor antagonist specifically developed for this indication. AbbVie says the approval was supported by data from a clinical program evaluating the drug’
Drugs
FDA has published a guidance, Q3B(R2) Impurities in New Drug Products, with recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or International Conference on Harmonization (ICH) member state. The
Drugs
FDA has published a draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, to help clinical investigators comply with safety reporting requirements for IND or IDE studies. The document has recommendations to help investigators identify (1) safety information for drugs that is considered an unanticipated problem involving risk
Drugs
FDA has published a draft guidance, Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, to assist manufacturers in ensuring the control of the microbiological quality of their non-sterile drugs. The document’s recommendations apply to solid, semi-solid, and liquid non-sterile dosage forms. FDA says the non-sterile
Drugs
FDA has published a draft guidance, Benefit-Risk Assessment for New Drug and Biological Products, to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that FDA makes about NDAs and BLAs.
Drugs
Researchers from the University of Chicago Booth School of Business say if FDA were to use a more data-driven approach in its postmarket drug analysis, there would be fewer cases in which safe drugs are wrongly penalized. To make their point, the researchers used different data to reanalyze the
Drugs
FDA has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients with Alagille syndrome age one and older. Mirum says Livmarli is a minimally absorbed ileal bile acid transporter inhibitor. It is the only FDA-approved medication for this rare liver disease. As part of the
Drugs
A panel of FDA staff from CDER and the Office of Regulatory Affairs provided the latest insight into common data integrity inspection findings during a 9/28 session at the annual FDA/Parenteral Drug Association regulatory conference. One common issue is firms’ review of electronic data, such as electronic chromatograms,