Nieuwsfeed
- Die letzte Woche: Mein liebes Tagebuch
- Instructions for Using the eBPDR System
- Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
- Biological Product Deviation Reporting -- Blood Product Codes
- Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
- General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
- A critique on “A randomized evaluation of on-site monitoring nested in a multinational randomized trial”
- Weekend reads: ‘The band of debunkers’; a superconductor retraction request; ‘the banality of bad-faith science’
- Arzneimittelkommission der deutschen Apotheker / Rückruf: Topiramat-neuraxpharm® 25, 50, 100 und 200 mg, 50, 100 und 200 Filmtabletten
- Trans Zorg Nu demonstreert 17 uur lang voor Radboudumc
- Advancing neurofibromatosis and schwannomatosis clinical trial design: Consensus recommendations from the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration
- The One Soft Skill That Many CRPs Are Missing
- FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types
- Cardiovascular and Renal Drugs Advisory Committee Roster
- Biosimilar Product Information
- Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding
- Shot of Joy LLC - 665936 - 09/25/2023
- Signature Biologics, LLC - 631039 - 09/18/2023
- Southern Tier Home Infusion, Inc. dba Pharmacy Innovations - 667414 - 09/20/2023
- Fresenius Kabi AG - 657085 - 09/14/2023
- Luis Javier Pena-Hernandez, M.D., FCCP - 668217 - 09/20/2023
- Human Drug Compounding
- Notable Approvals | Drugs
- The Tender Corporation dba Adventure Ready Brand - 599789 - 09/28/2023
- Tender Corporation - 599789 - 07/23/2020
- FDA Roundup: September 29, 2023
- User Fee Lists
- FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products
- Surgenex LLC - 615254 - 09/20/2023
- Surgenex LLC - 615254 - 11/15/2021
- Biologics Electronic Reading Room (eFOI)
- What’s New for Biologics
- Infinant Health, Inc formerly Evolve Biosystems Inc. - 667715 - 09/28/2023
- Jobs at the Center for Biologics Evaluation and Research (CBER)
- Tainted Arthritis | Pain Products
- Reumo Flex contains hidden drug ingredient
- Kuka Flex Forte contains hidden drug ingredient
- Tapee Tea contains hidden drug ingredients
- Conducting Remote Regulatory Assessments Questions and Answers
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (December 2022)
- CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities
- CPG Sec. 150.500 Analytical Methodology Used by FDA - Drugs
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
- Using a Centralized IRB Review Process in Multicenter Clinical Trials
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
- CPG Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes
- CPG Section 110.800 Post Detention Sampling Guidance for Industry
- CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
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