Devices
FDA has posted a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process. The document is intended to provide further clarification and updated information on the ISO standard to support applications submitted to FDA.
Biologics
FDA has accepted an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone) for treating pediatric growth hormone deficiency. The submission is supported by data from eight clinical trials evaluating safety and efficacy in more than 400 subjects, Ascendis says. The
Drugs
FDA has granted Project ALS an orphan drug designation for prosetin and its use in treating amyotrophic lateral sclerosis (ALS). The organization describes prosetin as an oral, brain penetrant MAP4 kinase inhibitor developed by scientists at Columbia University. Project ALS says it funded prosetin’s preclinical development and is sponsoring
FDA Policy/General
Federal Register notice: FDA has announced an 11/9 Medical Devices Advisory Committee Ophthalmic Devices Panel meeting. Panel members are scheduled to review a Refocus Group PMA for the VisAbility Micro Insert, indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the ages of
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Control of Nitrosamine Impurities in Human Drugs. The document recommends steps that active pharmaceutical ingredient and drug product manufacturers should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. It also describes conditions that may
Devices
FDA is reminding healthcare providers that it is important to conduct a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS). An agency letter to healthcare providers says that as part of FDA’s ongoing monitoring of the safety and effectiveness of
Drugs
Amylyx Pharmaceuticals announces clinical trial results published in the New England Journal of Medicine (NEJM) for amyotrophic lateral sclerosis (ALS) investigational drug AMX0035 showed a “clinically meaningful and statistically significant treatment benefit on the Revised ALS Functional Rating Scale (ALSFRS-R), the most commonly used scale in clinics worldwide to
Biologics
In a lengthy, detailed report, the Washington Post looks at the debate that has erupted around a nervous FDA over whether the agency should grant an emergency use authorization (EUA) to one or more coronavirus vaccines before clinical trials have been completed and analyzed. Proponents of an EUA say the
Drugs
FDA says CDER’s use of multiple sophisticated testing methods enabled it to determine that only eight of 16 metformin products that were reported by a private laboratory as containing levels of N-nitrosodimethylamine (NDMA) above allowable intake levels contained higher levels of NDMA. The Center then ordered the recall
Devices
FDA has cleared a SoftWave Tissue Regeneration Technologies 510(k) for using its SoftWave technology for treating superficial, partial-thickness, second-degree burns in adults. SoftWave technology uses an unfocused extracorporeal shock wave to “promote both a physical and biological response in order to improve wound healing,” the company says,
Drugs
FDA has issued a draft guidance, Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing, to assist sponsors in the design and analysis of studies assessing the influence of impaired renal function on pharmacokinetics and/or pharmacodynamics of an investigational drug. The document also
Drugs
Some 20 senators, led by Ted Cruz (R-TX), are asking FDA to classify the “abortion pill” Mifeprex (mifepristone) and its generic as an “imminent hazard to the public health” that “poses a significant threat of danger” and remove it from the U.S. market. In a 9/1 letter
Drugs
FDA has accepted for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer. The submission is supported by data from a single pivotal Phase 3 study. The company previously reported that the study achieved its primary endpoint by showing statistically significant improvement in overall
Drugs
FDA has granted Alphamab Oncology an orphan drug designation for KN046, a recombinant humanized antibody for treating thymic epithelial tumors. The thoracic tumors, mostly thymomas and thymic carcinoma, are inoperable and the metastatic ones have very poor prognoses, according to the company. Thymic epithelial tumor cells highly express PD-L1,
Drugs
Aerospace engineer Robert Zubrin says FDA is a “federal bureaucracy gone mad” that stifles drug innovations and should face significant cutbacks in its regulatory authority. In a National Review article that was picked up by Yahoo News, Zubrin says he started looking into the agency because FDA was blocking businesses
Drugs
FDA commissioner Stephen Hahn has ousted associate commissioner for external affairs John Wagner, a political appointee in his post for about two months, as part of the purge to right the ship in the wake of Hahn’s missteps in exaggerating convalescent plasma’s Covid-19 use (see earlier story)
Drugs
An NIH Covid-19 treatment guideline panel has refuted FDA’s recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treating of hospitalized patients with Covid-19. The panel 9/1 reviewed available evidence from published and unpublished data on convalescent plasma, including the FDA analyses
Drugs
Mylan has recalled four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-ups between the lots. The individual vials contained within the cartons are accurately labeled as amiodarone HCl or tranexamic acid, a recall
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should clarify that patents claiming the device constituent of a drug-device combination product approved in an NDA or a component thereof are drug product patents subject to Orange Book listing requirements. PhRMA states its position in its response to an
FDA Policy/General
Federal Register notice: FDA has determined that KV Pharmaceuticalֺ’s Micro-K LS (potassium chloride) extended-release liquid suspension, 20 milliequivalents/packet, was not withdrawn for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are
FDA Policy/General
Federal Register notice: FDA is correcting a 5/14 Federal Register notice on 16 NDA withdrawals from multiple applicants. The document indicated that FDA was withdrawing approval of NDA 050641, Aqua Pharmaceuticals’ Monodox (doxycycline monohydrate). Aqua has informed FDA that it did not want the NDA approval withdrawn. To view
FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to post-marketing pediatric-focused safety reviews of products posted between 9/23/2019 and 9/1/2020 but not being presented at a 9/15 Pediatric Advisory Committee meeting. Submit either electronic or written comments by