Drugs
FDA has approved a Bristol Myers Squibb and Acceleron Pharma BLA for Reblozyl (luspatercept-aamt), an erythroid maturation agent for treating anemia after failing an erythropoiesis stimulating agent and requiring two or more red blood cell units over eight weeks in adult patients with very low- to intermediate-risk myelodysplastic
Drugs
As president Trump and his allies daily tout the off-label use of the malaria drug hydroxychloroquine for treating caronavirus patients, former FDA commissioner Scott Gottlieb says that if the drug is working, its “effect is probably subtle enough that only rigorous and large scale trials will tease it out.
Drugs
A new Government Accountability Act report examined 637 NDAs submitted between 2014 to 2018 and found that while the agency met its review goals, differences in review times among the review divisions were “largely driven by the characteristics of the applications being reviewed.” The government watchdog agency was tasked with
Drugs
FDA has released a final guidance on “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744Kof the FD&C Act.” The document is intended for entities that compound human drugs and elect to register as outsourcing facilities under section 503B of the Federal Food, Drug, and
Drugs
DEVICES FDA has cleared a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner. The device features “Spectral Imaging” capabilities to perform image acquisition and processing at multiple energy levels for computed tomography. Neusoft says the scanner also offers 0.259 second rotation speed for
Drugs
FDA has posted a 3/5 FDA 483 citing a Dr. Reddy’s Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) facility conducted 3/1 to 3/5. According to the 483, FDA found the facility’s system for reprocessing APIs and API intermediates to be insufficient. For
Drugs
FDA has posted a 15-item FDA 483 issued 2/25 to Shilpa Medicare following an inspection of the firm’s Telangana, India drug manufacturing facility. The February inspection cited the company over its quality unit. For example, the unit failed to ensure that all production and laboratory control operations
Drugs
FDA has granted an emergency use authorization to Cellex for a coronavirus serology test. The assay is intended for use in CLIA-certified laboratories for detecting Covid-19 antibodies in blood samples. The test could help detect those who have previously been infected and had few, if any, symptoms. "
Drugs
FDA has approved a Celularity IND for its investigational stem cell therapy in Covid-19 patients. The company says it is planning a Phase 1/2 clinical study of CYNK-001 in 86 patients with Covid-19. The therapy has been at the center of a campaign directed by president
Drugs
FDA has released the FDA-483 issued following a 2/10-2/21 inspection at Biocon Sdn Bhd, a biotech firm in Johor, Malaysia. The three inspection observations were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failing to establish and follow
Drugs
The International Council on Harmonization is issuing a notification to users of the Medical Dictionary for Regulatory Activities (MedDRA) about existing and new terms for coronavirus concepts. The document says the Covid-19 pandemic “has prompted an urgent need for a harmonized standardized approach to coding and reporting the infection
Drugs
FDA has released the FDA-483 with 10 observations from a 3/2-3/10 inspection at Immunomedics, Inc., a Morris Plains, NJ, drug substance intermediate manufacturer. The observations were: * failing to establish procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related components; * failing
Drugs
FDA has given Vanda Pharmaceuticals approval to begin a clinical study, ODYSSEY VLY-686-3501, of tradipitant in hospitalized patients with Covid-19. The Phase 3 study will evaluate the therapy in treating and preventing pneumonia associated with Covid-19. It will randomize about 300 New York-area hospital patients
Drugs
A 3/30 Wiley Rein petition asks FDA to withdraw or rescind its 2/14 approval of a supplemental NDA switching GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium) topical gel 1% from Rx only to over-the-counter status. The petition says the OTC switch should be rescinded because “important
Drugs
AdvaMed says it is proposing minor revisions to improve the clarity and impact of an FDA draft guidance on bridging for drug-device and biologic-device combination products. The association’s comment letter says AdvaMed stands ready to assist the agency in finalizing the guidance and developing additional policies that
Drugs
The Trump administration continues to put pressure on FDA to speed access to potential coronavirus treatments. The latest effort has the White House supporting a decades-old flu drug to be used as a possible Covid-19 treatment. Politico reports that the drug, Fujifilm’s Avigan, has been touted by
Drugs
An 8/12-9/6/19 FDA inspection at Bulletproof 360, Seattle, WA, found serious violations of current good manufacturing practice (CGMP) regulations for dietary supplements, as well as other violations. A 3/20 Warning Letter says the agency determined that some of the firm’s supplements are considered to
Drugs
FDA is asking manufacturers to withdraw all prescription and over-the-counter ranitidine (Zantac and generics) products from the market immediately due to NDMA contamination that can increase over time. An agency news release says FDA has determined that the N-Nitrosodimethylamine impurity in some ranitidine products increases over time
Drugs
A 9/2-9/5/19 FDA inspection at Ficosota, Ltd., Shumen, Bulgaria, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/28 Warning Letter says specific violations were: * failing to have, for each batch of a drug product, appropriate laboratory determination
Drugs
An 8/22-8/27/19 FDA inspection at Trilogy Laboratories, Fort Myers, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A just-released 3/5 Warning Letter says specific violations were: * failing to perform, for each batch of a drug
Drugs
Board-certified psychiatrist David Behar, who says he has hundreds of former and dozens of current clozapine patients, is asking FDA to decommission the antipsychotic clozapine REMS program and allow healthcare professionals to rely on clinical judgment for treating and monitoring clozapine patients. Behar’s 3/9 petition specifically asks
Drugs
An 8/29-9/6/19 FDA inspection at Pfizer Healthcare India Private Limited, Andhra, Pradesh, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/25 Warning Letter says the firm failed to thoroughly investigate any unexplained discrepancy or failure of a