Drugs
FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018. In a 5/17 agency post, FDA provided a glimpse into its recent drug inspection activities. “As of fiscal year 2018, there were 4,676
Drugs
FDA has approved a Takeda Pharmaceuticals supplemental NDA to expand the indication for Gattex’s (teduglutide) for injection to pediatric patients aged one year and older with short bowel syndrome who need additional nutrition or fluids from intravenous feeding (parenteral support). Approval was based on data from a 24-week
Drugs
Three researchers say effort needs to be increased to incorporate patient-reported outcomes (PROs) as a data source for real-world evidence. Writing online in the journal Nature Reviews Drug Discovery, the researchers say that as pressures from legislation, international regulatory authorities, and patient groups promote more patient-centric drug
Drugs
FDA has approved an EMD Serono and Pfizer NDA for Bavencio (avelumab) in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen
Drugs
FDA has approved a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. VTE includes deep vein thrombosis and pulmonary embolisms, an agency release says. “Most children who have VTE are fighting a serious
Drugs
Iqvia Institute for Human Data Science says that over the next five years, clinical trial productivity will be heavily influenced by trends like biomarkers, pre-screened patient pools, and predictive analytics. The projection is in a white paper, “The Changing Landscape of Research and Development.” The analysis indicates that ongoing
Drugs
University of Florida researchers are working with CDER’s Office of Generic Drugs to develop an integrated bioinformatics approach to investigate potential claims of oral generic drug product bioinequivalence. A study report in the Journal of Clinical Pharmacology says that in the GDUFA 2012 letter of commitment, FDA committed to
Drugs
Pfizer says it supports risk-based approaches to clinical trial monitoring that can realize new efficiencies and facilitate strategies for clinical trial design and conduct. In comments on an FDA draft guidance on a risk-based approach to monitoring of clinical investigations, the company commends the authors of the guidance
Drugs
FDA has cleared an Aidoc 510(k) for its pulmonary embolism (PE) artificial intelligence (AI) product that helps radiologists flag and triage PE cases in chest computerized tomography scans. The company’s AI analyzes medical images directly after the patient is scanned and notifies radiologists on cases with suspected findings
Drugs
The Justice Department says FDA “lacks jurisdiction” to regulate articles, including drugs, intended for use in lawful executions. An opinion from the department’s Office of Legal Counsel says the agency has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment. Federal court
Drugs
The Pew Charitable Trusts says it supports the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act to modernize the monograph system by eliminating what it says is the “burdensome” rule-making process for changing monographs and expand FDA funding through user fees paid by manufacturers of over-the-
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 3 to 8 not to recommend approval of a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive, as detected by an FDA-approved test. Panel members appeared to
Drugs
FDA has approved a Genentech supplemental NDA for Venclexta (venetoclax) in combination with the company’s Gazyva (obinutuzumab) for treating people with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Approval is based on data from the Phase 3 CLL14 study, which evaluated a 12-month, fixed-duration treatment
Drugs
A class action suit has been filed against Gilead, Bristol-Myers Squibb, Japan Tobacco (Akros Pharma), and Janssen for engaging in a “long-running scheme to restrain competition with respect to some of the most important drugs used to treat HIV/AIDS.” The suit says that through an array of
Drugs
Janssen says it recognizes and appreciates FDA efforts to issue a draft guidance related to quality considerations for continuous manufacturing. In a comment letter, the company says it supports the draft guidance content and believes that once it is finalized, all stakeholders will receive significant benefits. The letter lists several
Drugs
A 12/17-12/21/18 FDA inspection at Petra Hygienic Systems International, Concord, Ontario, Canada, found repeat current good manufacturing practice (CGMP) violations in the firm’s manufacturing of finished pharmaceuticals. A 5/17 Warning Letter says the inspection observations were: * failing to have, for each batch of drug
Drugs
FDA says it has sent Warning Letters to five companies that produce products labeled as homeopathic for significant violations of current good manufacturing practice regulations. An agency media release says four of the letters pertain to companies that jointly produced a product labeled as homeopathic that posed a significant risk
Drugs
CDER has issued its latest “Report on the State of Pharmaceutical Quality,” a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products. The report says CDER’s Office of Pharmaceutical Quality monitors the quality of CDER-regulated drugs legally marketed in the U.S. It
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that a draft guidance on “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients” should be applicable across other therapeutic areas, as appropriate. In comments on the guidance, PhRMA says it believes that the considerations for inclusion of pediatric patients in
Drugs
A new study published online in JAMA finds that pharmaceutical companies often conducted clinical trials after winning FDA approval, but most were not related to the approved use unless directed by the agency in a postmarketing requirement or commitment at initial approval. The study, conducted by researchers at Tufts School
Drugs
A 10/15-11/1/18 FDA inspection at Bershtel Enterprises, Duarte, CA, found violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/2 Warning Letter says specific inspection observations were: * failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug
Drugs
In a unanimous decision, the Supreme Court has said that whistleblowers will have up to four years of additional time to file False Claims Act (FCA) suits against healthcare and other firms. The justices said that FCA claimants can sue up to three years after the responsible federal official knew