FDA warning letter

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course - ResearchAndMarkets.com

Retrieved on: 
Friday, September 29, 2023
Pharmaceutical, Health, Other Manufacturing, Manufacturing, Ohio State University, API, ICH, Chesapeake Biological Laboratory, The Compendious Book on Calculation by Completion and Balancing, Organization, Genetics, ASQ, CGMP, Water, Michigan State University, Clutch (eggs), Environment, FDA warning letter, Dietary supplement, Medical device, Fine chemical, Microbiology, Q9

Explore raw material requirements, including the significant impact of water (the largest raw material in most processes), while ensuring compliance with cGMP guidelines such as ICH Q7, Q9, and Q11.

Key Points: 
  • Explore raw material requirements, including the significant impact of water (the largest raw material in most processes), while ensuring compliance with cGMP guidelines such as ICH Q7, Q9, and Q11.
  • Discussions on various issues related to raw materials, including testing requirements, compendial vs. non-compendial testing, regulatory risks, and more.
  • The objective of this online two-day highly interactive seminar is to explore raw materials and their requirements - issues and solutions.
  • Upon completing this course on raw material requirements in a cGMP environment participants will:
    Understand how various types of raw materials may impact the user.

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment: Issues and Solutions Online Training Course

Retrieved on: 
Thursday, May 4, 2023
Biotechnology, API, Health, ICH, USP, Tablet, Phase 1, Capsule, ASQ, CGMP, Water, EP, ONLINE, Clutch (eggs), WCS, Environment, Phase, FDA, Health Canada, FDA warning letter, Online shopping, Audit, Fine chemical, Dietary supplement, Explosive, Synthetic oil

DUBLIN, May 3, 2023 /PRNewswire/ -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 3, 2023 /PRNewswire/ -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ResearchAndMarkets.com's offering.
  • The objective of this FIVE-HOUR/DAY, ONLINE two-day highly interactive WCS seminar is to explore raw materials and their requirements - issues and solutions.
  • Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.
  • Raw material requirements in a cGMP environment are often overlooked as a Company develops new products.

CorMedix Inc. Announces Regulatory and Manufacturing Updates

Retrieved on: 
Thursday, March 2, 2023
DMF, Documentation, New Drug Application, FDA warning letter, Agency, FDA, API, NDA, Type, Heparin, State, CMO, Letter, Pharmaceutical industry, Dietary supplement, Medical device

The supplier has also informed CorMedix that subsequent to those updates, a supplement to an approved application referring to this DMF was recently approved by FDA.

Key Points: 
  • The supplier has also informed CorMedix that subsequent to those updates, a supplement to an approved application referring to this DMF was recently approved by FDA.
  • CorMedix hopes to obtain guidance from FDA on these two important issues in a Type A meeting.
  • CorMedix will provide additional clarity on these pathways on its year-end earnings call in March, and subsequent updates following its anticipated Type A meeting with FDA.
  • I am hopeful to have additional updates on our year-end earnings call or shortly thereafter.”

Online Seminar: Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions - ResearchAndMarkets.com

Retrieved on: 
Monday, July 18, 2022
Hospitals, Health Technology, Practice Management, Biotechnology, Other Natural Resources, Health, Pharmaceutical, General Health, Natural Resources, FDA warning letter, Solution, Health Canada, Capsule, Phase, Phase 1, Water, Health, Environment, ASQ, Biotechnology, USP, Tablet, ICH, Company, CGMP, API, EP, Particle-size distribution, Review, Compliance, FDA, Dietary supplement, Audit, Fine chemical, Explosive, Pharmaceutical industry, Synthetic oil

The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions" training has been added to ResearchAndMarkets.com's offering.
  • The objective of this FIVE HOUR/DAY, ON-LINE two day highly interactive seminar is to explore raw materials and their requirements - issues and solutions.
  • Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.
  • Raw material requirements in a cGMP environment are often overlooked as a Company develops new products.

Kiromic BioPharma Announces Company Will Directly Submit Amended IND for Procel™ to the FDA in Second Half of 2022

Retrieved on: 
Wednesday, May 11, 2022
FDA, Technology, Pharmaceutical, Oncology, General Health, Medical Devices, Infectious Diseases, Genetics, Clinical Trials, Other Technology, Science, Biotechnology, Other Science, Health, Research, Drug development, IND, Twitter, NASDAQ, Data mining, Chemistry, Company, Securities Exchange Act of 1934, Cell engineering, FDA warning letter, CGMP, Clinical trial, FDA, Letter, GMP, Annual report, GDT, ALEXIS, Private Securities Litigation Reform Act, Cuernavaca, LinkedIn, CMC, Gamma delta T cell, SEC, Terminology, Kirom Bukhoroi, Pharmaceutical industry

A cGMP mammalian master cell bank is a significant step forward in the Companys clinical pathway and would address a key issue identified by the FDA in the clinical hold letter.

Key Points: 
  • A cGMP mammalian master cell bank is a significant step forward in the Companys clinical pathway and would address a key issue identified by the FDA in the clinical hold letter.
  • We are very pleased to share these significant regulatory updates, reflecting the progress we have been making as a Company.
  • From its heritage as a cancer vaccine development company, Kiromic is focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline.
  • We undertake no obligation to update any forward-looking statements except to the extent required by law.

Kaleido Biosciences Investor Alert: Kaplan Fox Investigates Potential Securities Fraud at Kaleido Biosciences, Inc.

Retrieved on: 
Tuesday, April 12, 2022
Company, FDA warning letter, Letter, IND, SEC, Nasdaq, Failure, Food, Form FDA 483, Regulation of tobacco by the U.S. Food and Drug Administration, GLOBE, News, FDA, Pharmaceutical industry, Online gambling

NEW YORK, April 11, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is investigating claims on behalf of investors of Kaleido Biosciences, Inc. (Kaleido Biosciences or the Company) (Nasdaq: KLDO).

Key Points: 
  • NEW YORK, April 11, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is investigating claims on behalf of investors of Kaleido Biosciences, Inc. (Kaleido Biosciences or the Company) (Nasdaq: KLDO).
  • Following this news, Kaleido Biosciences shares fell nearly 82% to close at $0.2699 per share on April 8, 2022.
  • If you purchased or otherwise acquired Kaleido Biosciences securities and would like to discuss our investigation, please contact us by emailing [email protected] or by calling (646) 315-9003.
  • Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions.

Scott+Scott Attorneys at Law LLP Announces Investigation into Owlet, Inc. (OWLT)

Retrieved on: 
Thursday, October 28, 2021
Legal, Professional Services, Foundation, Law, FDA warning letter, Bradycardia, Desaturation, FDA, NYSE, Food, Marketing, Food and Drug Administration, Company, Smart, OWLT, Cryptocurrency, Dietary supplement

Scott+Scott Attorneys at Law LLP (Scott+Scott), an international shareholder and consumer rights litigation firm, is investigating whether Owlet, Inc. (Owlet or the Company) (NYSE: OWLT) and certain of its officers and directors violated federal securities laws by making materially misleading statements to investors.

Key Points: 
  • Scott+Scott Attorneys at Law LLP (Scott+Scott), an international shareholder and consumer rights litigation firm, is investigating whether Owlet, Inc. (Owlet or the Company) (NYSE: OWLT) and certain of its officers and directors violated federal securities laws by making materially misleading statements to investors.
  • If you purchased or otherwise own Owlet stock, and have suffered a loss, you are encouraged to contact Scott+Scott attorney, Rhiana Swartz, at [email protected] or (844) 818-6980 for more information.
  • Pursuant to the Warning Letter, the Company suspended distribution of the Smart Sock in the United States as of October 22, 2021.
  • The firm represents pension funds, foundations, individuals, and other entities worldwide with offices in New York, London, Amsterdam, Connecticut, Virginia, California, and Ohio.

Two Day Virtual Data Integrity Course: FDA, WHO and EMA's Requirements - November 15th-16th, 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, October 28, 2021
Health, General Health, WHO, Data, NextGen Healthcare, EMA, Corporation, Compliance, CGMP, Data integrity, FDA, FDA warning letter, Dietary supplement

The "Data Integrity: FDA, WHO and EMA's Requirements" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Data Integrity: FDA, WHO and EMA's Requirements" training has been added to ResearchAndMarkets.com's offering.
  • The objective of this two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimise these issues.
  • This seminar is designed to assist in assuring that your organisation is maintaining itself within cGMP compliance.
  • This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Diamond Therapeutics Hires Industry Veteran David Brown, PhD, to Further Advance Formulation of Psilocybin

Retrieved on: 
Monday, July 26, 2021
Life sciences, Health sciences, Articles, Patheon, Teva Pharmaceuticals, Pharmaceutical industry, Psychedelic drug, Teva

Brown has an impressive track record of experience, having held senior positions at leading pharmaceutical companies, including Patheon, Teva and Impopharma.

Key Points: 
  • Brown has an impressive track record of experience, having held senior positions at leading pharmaceutical companies, including Patheon, Teva and Impopharma.
  • His broad expertise includes program management; he has successfully taken projects from pipeline selection and project concept through to commercialization.
  • At Diamond, Brown will be heading cutting-edge research and development regarding the formulation of low-dose psychedelics for pharmaceutical uses and the synthesis of novel compounds.
  • Dalton is one of only a few Canadian companies to successfully manufacture cGMP psilocybin for prospective use in regulatory submissions.

AcelRx Announces Agreement with FDA Addressing the Warning Letter Received for DSUVIA® Promotional Materials

Retrieved on: 
Thursday, June 17, 2021
Food and Drug Administration, United States Public Health Service, Dynamic Host Configuration Protocol, FDA warning letter, Food law, Health

TheFDA has agreed with AcelRx's proposed plan to update certain promotional materials, including providing a letter to healthcare professionals (DHCP letter) explaining the corrections to the discontinued promotional materials.

Key Points: 
  • TheFDA has agreed with AcelRx's proposed plan to update certain promotional materials, including providing a letter to healthcare professionals (DHCP letter) explaining the corrections to the discontinued promotional materials.
  • AcelRx will also include this DHCP letter on the DSUVIA.com website for a period of eight months.
  • All promotional materials currently in use by AcelRx's commercial team have been updated to address the FDA's concerns.
  • This press release contains forward-looking statements, including, but not limited to, statements related to the FDA warning letter, including the expected receipt of a close-out letter from the FDA.