21st Century Cures Act

The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in the development of new drugs, biologics, and medical devices. A relatively new law, the 21st Century Cures Act, was designed...

by | Jan 23, 2023

The 21st Century Cures Act was designed to bring medical products and innovations to patients in need faster and easier.

The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in the development of new drugs, biologics, and medical devices. A relatively new law, the 21st Century Cures Act, was designed as a way to bring these medical products and medical innovations to patients in need, faster and easier.

Signed into law in December of 2016, the Cures Act helps to organize clinical trials in a way that allows their outcomes to be easily assessed. Modernizing clinical trials helps ensure medical products and new drug treatments will reach the market and patients in need faster than they did previously. Additionally, the act helps regulate activity within and between the disease, drug, biologic, and medical device industries. This improves the time required for combination products to reach the market.

Additionally,  in an effort to support emerging scientists, the Cures Act creates policies and opportunities for new researchers. Clinical trials are also impacted by this act, requiring less documentation and more informal data to understand whether a treatment or strategy is safe and effective.

Contract Laboratory is always receiving test requests from companies needing their drug, medical devices, and biological products testing, as well as testing and research for diseases and clinical trials. The following are some of these most recent test requests. To see more, visit our website.

  • Medical device company needs virology laboratories for virus testing of surgical products Biologics
  • Europe GMP bioanalytical laboratory needed for physiochemical testing of biologics: pH, Osmolality, appearance, LC-based methods Bioassays: ligand binding and cell-based assays
  • LONG-TERM TESTING A Pharmaceutical company needs a product safety laboratory for the General Safety Test of Biologics Testing as described in CFR 21 610.11 GENERAL BIOLOGICAL PRODUCTS STANDARDS,. Approximately 800 tests annually
  • Medical Device company needs a biomedical laboratory to run several tests using human blood pumped through a flow loop and assay for the concentration of several analytes that are spiked into the flow path.
  • LONG-TERM Contract Sterilizer needed for gamma sterilization of medical devices starting at 300,000 units and going to 1 million in a year
  • Medical Device laboratory needed for CE Mark biomechanical testing of silicone liners for lower limb prostheses (amputees) to ISO Standard 10328:2006 mechanical tests (torsional testing – static testing)
  • Medical device laboratory needed for physical testing of transfusion sets to the physical requirements of ISO 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
  • A pharmaceutical laboratory is needed for the analysis of herbal cold products for the presence of Amygdalin and the concentration of Hydrocyanic acid.
  • Pharmaceutical analytical chemistry laboratory needed for United States Pharmacopeia (USP) 27 testing for extractables and light transmission.
  • US pharmaceutical company needs a contract sterilizer in India for sterilization.
  • A pharmaceutical company needs a clinical laboratory for Mossbauer and ESR testing under GMP conditions
  • Company interested in acquiring an analytical laboratory in Saudi Arabia for the testing for quality assurance, testing, inspection, and certification of Agrochemicals & Pesticides, Basic & Industrial Chemicals, Dyes & Detergents, Lubricants & Greases, Nanomaterials, Petrochemicals, Polymers & Plastic, Food, Medical Devices, Pharmaceuticals, Beauty & Personal Care Products
  • Bioanalytical laboratory needed to conduct 3 studies as part of food clinical trials including 1- Study of the changes in fecal bacteria populations using 16SrRNA probes labeled with Cy3 for specific bacterial groups or the nucleic acid stain DAPI for total bacterial counts. The bacterial groups selected for enumeration will be Bifidobacterium spp., Bacteroides/Prevotella spp., Lactobacillus/Enterococcus spp., Clostridiumcoccoides- Eubacterium rectale group, Clostridium histolyticum group, and Atopobium cluster including most Coriobacteriaceae species, using the specific probes Bif164, Bac303, Lab158, Erec482, His150, and Ato291, respectively 2. Fluorescence in situ Hybridisation (FISH), as described by Rycroft et al. (2001) and Daims et al. (2005). Briefly, fecal samples (375?l) fixed in 4% paraformaldehyde (pH7.2) overnight at 4 degrees C were then centrifuged at 1500 ×g for 5 min, washed twice with phosphate buffer saline (PBS0.1M,pH7.0), re-suspended in a mixture of PBS/99% ethanol (1:1v/v) and stored at ?20?C for up to 3 months. For the hybridizations, 20? l of each sample was pipetted onto Teflon-and poly-l-lysine-coated, six-well (10mm diameter each) slides. Slides were dried at 46C for 15 min and then submerged in a series of ethanol solutions (50, 80, and 96%, 3 min each). This process was used for all samples, except those where the Lab 158 probe was used. Sample slides probed with Lab 158 were subjected to an additional step with 50 ?l of lysozyme (1mg/mL in 100 Tris-HCl, pH8.0) at 37 deg C for 15 min prior to being submerged in the ethanol solutions. A probe/hybridization buffer mixture (5 ?l of a 50ngstock of probe plus 45 l of hybridization buffer) was applied to the surface of each well. Hybridizations were performed for 4 hours in an ISO20 oven (Grant Boekel). Slides were stored in the dark at 4 deg C (for a maximum of 3 days) until cells were counted. Slides were enumerated using a Nikon E400 Eclipse microscope fitted with an EPI-fluorescence attachment, 15 randomized views were counted for each sample. 3. Plasma propionate

Looking for a laboratory to perform your medical device, drug, biologic, or other clinical trial testing or research? We can help save you time and money, call 1-855-377-6821 or visit our website to submit a test request today!

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