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Drug Test
  • February 12, 2025

Evaluation of Bladder Wash as an Alternative Specimen for Postmortem Toxicology: Comparison to Screening Results of Urine and Kidney Tissue

Urine specimens represent the gold standard for screening analyses in forensic toxicology but are not always available postmortem. The current…
diversity-action-plans-to-improve-enrollment-of-participants-from-underrepresented-populations-in-clinical-studies Drug Test
  • February 12, 2025

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
study-of-sex-differences-in-the-clinical-evaluation-of-medical-products Drug Test
  • February 12, 2025

Study of Sex Differences in the Clinical Evaluation of Medical Products

This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific…
questions-and-answers-on-current-good-manufacturing-practices-for-drugs Drug Test
  • February 11, 2025

Questions and Answers on Current Good Manufacturing Practices for Drugs

As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be…
search-for-regulatory-references-|-drugs Drug Test
  • February 11, 2025

Search for Regulatory References | Drugs

Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
drug-quality-sampling-and-testing-programs Drug Test
  • February 11, 2025

Drug Quality Sampling and Testing Programs

FDA CDER’s quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
fda-approves-mirdametinib-for-adult-and-pediatric-patients-with-neurofibromatosis-type-1-who-have-symptomatic-plexiform-neurofibromas-not-amenable-to-complete-resection Drug Test
  • February 11, 2025

FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult…
fda-clarifies-policies-for-compounders-as-national-glp-1-supply-begins-to-stabilize Drug Test
  • February 11, 2025

FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has…
chengdu-innovation-pharmaceutical-co,-ltd.-–-698786-–-02/05/2025 Drug Test
  • February 11, 2025

Chengdu Innovation Pharmaceutical Co., Ltd. – 698786 – 02/05/2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
isothrive,-inc.-–-688547-–-02/04/2025 Drug Test
  • February 11, 2025

ISOThrive, Inc. – 688547 – 02/04/2025

Clinical Investigator