Drugs
FDA has issued a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische after inspecting the firm in February and citing GMP deviations. The letter says the firm failed to establish adequate written procedures for production and process controls, and provide data to demonstrate that
Drugs
Biogen has agreed to pay $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs. The whistleblower (qui tam) lawsuit was brought by former Biogen
Drugs
The Association of Health Care Journalists (AHCJ) is urging is journalist members to look deeper into FDA’s use of advisory committees in their regulatory decision making and the transparency about the agency’s decisions on when to seek expert feedback and instructions to its advisory committees. A 9/23
Drugs
Federal Register final rule: FDA is amending the color additive regulations to allow calcium carbonate’s use in dietary supplement tablets and capsules. This action is in response to a color additive petition submitted by Colorcon, Inc. To view the notice, click here.
Drugs
FDA has released three Form FDA-483s issued to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-insulin, and insulin aspart,
Drugs
After three and a half years at the helm, CDER Office of Generic Drugs (OGD) director Sally Choe is leaving FDA effective 10/8 to “pursue opportunities outside the agency,” according to Center director Patrizia Cavazzoni. Choe rejoined FDA from a stint in industry in 2016 as CDER Office of
Drugs
Former New York cannabis programs director Norman Birenbaum has joined CDER’s Office of the Center Director as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis as a part of CDER’s work in controlled substances,” according to deputy Center director
Drugs
FDA is likely to expand its use of new FDA Medical Queries (FMQs ) on many NDAs and BLAs during their safety reviews, and incorporating the results in labeling, according to former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger, who earlier this year joined Hyman, Phelps &
Drugs
FDA has posted a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. The draft outlines and explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, such as scientific necessity for conducting it
Drugs
FDA has made available an “immediately-in-effect guidance” entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency. The document is intended to increase public availability of, and access to,
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should expand the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program to include human cell and tissue products regulated by CBER and products using digital health technologies in support of their applications. Commenting on an agency RTOR draft
Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA’s efforts in providing a draft guidance on therapeutic equivalence (TE) evaluations and the assignment of TE codes. The AAM says its members have suggestions for how the draft guidance can provide even more transparency into FDA’s TE evaluations
Drugs
Senate Health, Education, Labor and Pensions Committee leaders have reached a compromise to reauthorize FDA’s user fee programs for an additional five years. The reauthorization package, which is “practically clean” with few policy riders, will likely be attached to a continuing resolution that Congress is expected to take up
Drugs
FDA has granted regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating adult patients with locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. The agency also approved Thermo Fisher
Drugs
Staff in the FDA Oncology Center of Excellence say new procedures are needed for oncology drug accelerated approvals to shorten the time between approval and the completion of a confirmatory study. “The time between accelerated approval and verification or refutation of clinical benefit is a period of uncertainty,” the staffers
Drugs
FDA’s Oncologic Drugs Advisory Committee 9/22 voted 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals’ Pozenveo (poziotinib) and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human epidermal growth factor receptor 2 exon 20 insertion mutations. FDA
Drugs
FDA has made available a draft guidance entitled “How to Obtain a Covered Product Authorization.” The document describes how eligible product developers can obtain such authorizations from FDA under the CREATES Act. The law provides a pathway to obtain product samples needed to fulfill testing and other regulatory requirements from
Drugs
FDA has released the form FDA-483 issued following an 8/16-8/26 inspection at the Cipla drug manufacturing facility in Goa, India. The five inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * procedures designed to prevent microbiological contamination of drug products
Drugs
FDA has approved Fennec Pharmaceuticals’ Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month and older with localized non-metastatic solid tumors. An agency notice says the drug’s efficacy was evaluated in two multi-center open-label trials in pediatric patients
Drugs
FDA has approved a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced magnetic resonance imaging (MRI). The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the
Drugs
FDA has lifted a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with HIV-1 infection. The studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of
Drugs
FDA is stepping up its drug inspections in India and plans to have more short-notice inspections, according to the Economic Times. The newspaper says it was informed by FDA country director for India Sarah McMullen that the agency is nearing pre-pandemic levels in terms of inspection activity.