Drugs
In an unusual 8/1 “Dear Americans” open letter, FDA commissioner Robert Califf and Drug Enforcement Administration (DEA) administrator Anne Milgram say the current shortage in prescription stimulants is not a problem the two agencies can solve on their own. “We are urging all stakeholders to work together to resolve
Drugs
FDA has granted Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer. Elraglusib is described as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor that targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such
Drugs
A 7/28 Warning Letter cites Sanand, India-based Intas Pharmaceuticals for current good manufacturing practice (CGMP) violations found during an 11/22/22-12/2/22 FDA inspection. The letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility to ensure drug
Drugs
A 1/30-2/10 FDA inspection at the Iso-Tex Diagnostics drug manufacturing facility in Alvin, TX, found significant violations of current good drug manufacturing (CGMP) regulations for finished drugs. A 7/20 Warning Letter says specific violations were: * failing to have buildings used in the manufacturing, processing, packing,
Drugs
A 1/19-1/27 FDA inspection at the Baxter Pharmaceuticals India drug manufacturing facility in Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/25 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has cleared a Teleflex 510(k) for expanded use for the QuikClot Control+ Hemostatic Device — mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding following a sternotomy. The company says the expanded use now allows physicians to use the device to control all bleeding in cardiac
Drugs
FDA has approved a GSK supplemental BLA for Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by single agent Jemperli for treating adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test. Approval was based on data
Drugs
Democratic U.S. Senators Ben Cardin (D-MD), Tina Smith (D-MN), and Richard Blumenthal (D-CT) have introduced legislation that would give FDA and Centers for Medicare and Medicaid Services (CMS) additional authority to address drug shortages. The bill, the Drug Shortages Prevention and Quality Improvement Act (S 2586)
Drugs
FDA has issued Citius Pharmaceuticals a complete response letter on its BLA seeking approval for Lymphir (denileukin diftitox), an engineered interleukin-2 diphtheria toxin fusion protein for treating patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. The letter says that the company
Drugs
FDA and Switzerland 7/27 have entered into a mutual recognition agreement (MRA) where each regulatory agency can rely on the other’s factual findings from a good manufacturing practice (GMP) inspection of a pharmaceutical manufacturing facility. The regulatory agencies signed the agreement 1/12, but it was contingent on
Drugs
FDA and the European Medicines Agency (EMA) have completed the first collaborative assessment of a proposed post-approval change for a critical cancer biologic with Japanese regulators serving as an observer. The collaboration resulted in approval for the undisclosed manufacturer to add new manufacturing and quality control sites for increasing
Drugs
A Government Accountability Office (GAO) review of FDA’s over-the-counter (OTC) drug monograph program performance based on enhancements provided by Congress in the 2020 CARES Act says that the agency has not begun receiving any OTC monograph order requests, and they do not expect to do so until
Drugs
A Catalent facility in Brussels, Belgium, that fills syringes for Novo Nordisk’s weight loss drug Wegovy has had FDA compliance issues in recent years affecting product sterility. Reuters reports that it used a Freedom of Information Act request to obtain FDA inspection reports on the Catalent facility. The news
Drugs
FDA has told BioHaven that it will not review the company’s NDA for toriluzole to treat spinocerebellar ataxia because a Phase 3 study failed to meet its primary endpoint and thus the agency cannot perform a substantive review. The company says it is requesting a Type A meeting with
Drugs
Sen. Gary Peters (R-MI) has introduced bipartisan legislation, the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act, to increase resiliency and readiness in the drug supply chain, easing drug shortages and preparing for future public health threats. A statement says the bill would require HHS to award contracts
Drugs
Sun Pharma is asking FDA to ask the manufacturers of unapproved phenobarbitol products to recall drugs that contain excipients that are known to be harmful to neonates. It also is asking the agency to inform the public and healthcare providers about the “serious risks associated with the use of unapproved
Drugs
FDA has released the form FDA-483 issued following a 2/27-3/30 inspection at Central Admixture Pharmacy Services, an Allentown, PA, outsourcing facility. The six inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet
Drugs
FDA has published a guidance, CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality, to describe the agency’s participation in the development and use of technical voluntary consensus standards that are integral to its mission. The document says FDA has used such standards to
Drugs
FDA has approved an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients needing urgent surgery or invasive procedures. Balfaxar is a non-activated four-factor prothrombin complex concentrate (4F-PCC)
Drugs
Defender Pharmaceuticals has submitted an NDA for its intranasally administered scopolamine gel (DPI-386 Nasal Gel) for preventing motion-caused nausea and vomiting in adults. Scopolamine has been marketed for decades in a transdermal patch formulation and Defender believes its unique intranasal gel formulation offers the ability to bring faster
Drugs
FDA has cleared a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medium-sized laboratories. The device uses standardized assays and reagents, the company says, adding that it offers a “broad menu of 120-plus assays. The analyzer
Drugs
FDA says that a “reverse-FOIA [Freedom of Information Act]” lawsuit seeking to keep an unnamed company attorney’s identity secret (see earlier story) in connection with a form FDA-483 should be dismissed because the suit failed to state a claim for which relief can be granted. The suit,