Drugs
The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations have petitioned FDA to ask Danco Laboratories to submit a supplemental NDA for Mifeprex (mifepristone), indicated for medical termination of pregnancy, to add “miscarriage management” to the drug’s indication. The petition also asks the agency to
Biologics
FDA has approved GlaxoSimthKline Biologicals’ Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis (whooping cough) in infants younger than two months of age. Most serious pertussis cases, hospitalizations and deaths occur in infants younger than
FDA Policy/General
Federal Register proposed rule: FDA is proposing a regulation to implement its new authority to destroy a device valued at $2,500 or less that has been refused admission into the U.S. The agency contends the public health benefit of the proposed rule would be the value of preventing
FDA Policy/General
Federal Register notice: FDA is announcing the rates for biosimilar user fees for fiscal year 2023. They are: * Applications requiring clinical data: $1,746,745 * Applications not requiring data: $873,373 * Initial biological product development (BPD) fee: $47,325 * Annual BPD: $47,325 * BPD reactivation: $94,650 * Program fee: $304,
Devices
FDA has issued Abbott Molecular an emergency use authorization for its Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. This is the first commercial test kit to be authorized for detection
Drugs
FDA has approved an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran), an RNAi therapeutic indicated for treating primary hyperoxaluria Type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients. The drug was originally approved 11/2020 for treating
Drugs
An FDA briefing document released in advance of a 10/17-19 advisory committee meeting to discuss whether the accelerated approval of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) should be withdrawn argues strongly that the drug is not effective and has known risks. It was approved
Devices
Fresenius Kabi has recalled its Ivenix Infusion System’s large volume pump software due to a software design issue. A recall notice says the display screen may become “frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a
FDA Policy/General
FDA chief medical officer Hilary Marston and Office of Clinical Policy director Ann Meeker-O’Connell say the agency is modernizing its oversight of clinical research and harmonizing with the HHS Common Rule protecting people who participate in research to make clinical trials more efficient and improve information for potential
Drugs
Yale University researchers say their review of drug safety signals identified from the FDA Adverse Event Reporting System (FAERS) between 2008 and 2019 suggested ways FDA could ensure timely and robust assessment of potential safety signals. Writing in the BMJ, the researchers offer three considerations: * set deadlines for reviewing safety
Devices
FDA has cleared a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers. IHControls is intended to ensure that all immunohistochemistry (IHC) tests, on all patient samples, are performed correctly, according to the company. “Any variation in the IHC reagents, instrument, or protocol
Drugs
CDER and CBER say they are partnering with the Critical Path Institute to begin planning for a consortium to develop tools appropriate for use in clinical development programs for alpha-1 antitrypsin deficiency (AATD). An FDA statement says there’s “an urgent need for biomarkers in AATD that would predict
Devices
FDA says it has changed the status of the Bayer Essure postmarket surveillance study to “progress inadequate.” A 10/6 Essure information update says the status change for the birth control device study is due to the increase in interim lost to follow-up rates in both the Essure and
Drugs
FDA has granted Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with weight-related comorbidities. After obtaining input from the agency, Lilly says it will initiate a rolling NDA submission this year. It will be based on data from two
Devices
Federal Register notice: FDA has announced the medical device user fee rates and payment procedures for fiscal year 2023. For example, here are some of the more common standard fee rates: * PMA/BLA/PDP: $441,547 * Efficacy (BLA) supplement: $441,547 * Panel-track supplement: $353,238 * De novo classification request:
Devices
FDA has cleared an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System. The device is intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, according to the company. Comprising a transfixing-cone, an ilium screw, a sacrum screw and associated instrumentation, the device is
FDA Policy/General
Federal Register notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2023. They are: * Application Requiring clinical data: $3,242,026 * Application not requiring clinical data: $1,621,013 * Program fee $393,933 To view the notice, click here.
Drugs
Researchers from Harvard and Yale Universities and Kaiser Permanente say that among postmarket requirements and postmarket commitments issued to new FDA-approved drugs between 2013 and 2016, about 75% of those due by 2020 were not submitted on time. Writing in a JAMA Internal Medicine Research Letter, the researchers say
Drugs
FDA has published two final guidances it says are intended to enhance patient safety by facilitating timely initiation of post-approval studies (PAS) and postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act. “The guidances are also intended to increase transparency to stakeholders on FDA’s
Devices
FDA has approved a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Roche says HER2 is
FDA Policy/General
Federal Register notice: FDA has announced a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Specialty supplemental NDA for Revatio (sildenafil citrate tablets), indicated for treating pediatric patients with pulmonary arterial hypertension. The panel will also discuss the results of the postmarketing safety study titled
FDA Policy/General
Federal Register notice: FDA has announced a 12/13 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Cytokinetics NDA for omecamtiv mecarbil tablets, indicated to reduce the risk of cardiovascular death and heart failure events in patients with symptomatic chronic heart failure with reduced ejection fraction. Panel members