24 SEPTEMBER - CDER has released a list of guidances they plan to develop.
www.fda.gov/cder/guidance/guidance-agenda.htmGuidance Agenda:Â Guidances CDER is Planning to Develop During Fiscal Year 2003CATEGORY — Advertising* Advertising and Labeling of Treatment IND Protocols* Patient Reported Outcomes* Promotion of Combination Oral Contraceptive ProductsCATEGORY — Biopharmaceutics* Clozapine Tablets – In Vivo Bioequivalence and In Vitro Dissolution TestingCATEGORY — Chemistry* Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA Technology* Drug Products: Chemistry, Manufacturing, and Control Documentation* Drug Substance: Chemistry, Manufacturing, and Control DocumentationCATEGORY — Clinical/Medical* Acne Vulgaris* Analgesics* Clinical Development Programs for MDI and DPI Drug Products – Revision* Clinical Evaluation of Drugs for the Treatment of Acute Coronary Syndrome* Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy in Postmenopausal Women – Revision* Clinical Evaluation of Drugs for Neuropathic Pain* Clinical Evaluation of Drugs for the Treatment of Heart Failure* Collection and Use of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products* Development of New Opiate Formulations* Drug-Coated Cardiovascular Stents* Evaluation of New Treatments for Diabetes Mellitus* Gingivitis* Safety Review of Clinical DataCATEGORY — Clinical/Pharmacology* Format and Content of the Clinical Pharmacology Section of Prescription Drug Product Labeling* Immediate Release to Modified Release Dosage Forms* In Vitro Drug Metabolism/Drug Interaction – Guidance for ReviewersCATEGORY — Compliance* Current Good Manufacturing Practices for Compressed Medical Gases – Revision* Maintaining Adequate and Accurate Records During Clinical Investigations* National Drug Code Number and Drug Product Labels* Describing How PET Drug Products May Comply With New CGMP Requirements – Revision* Sterile Drug Products Produced by Aseptic ProcessingCATEGORY — Electronic Submissions* Providing Electronic Submissions to the Division Of Drug Marketing, Advertising, and Communications* Providing Electronic Submissions in Electronic Format: Marketing Applications and Related Submissions* Providing Regulatory Submissions in Electronic Format – Annual Reports for Approved NDAs* Providing Regulatory Submissions in Electronic Format – General Considerations* Providing Regulatory Submissions in Electronic Format: Postmarketing Periodic Adverse Drug Experience Report* Scope and Implementation of Part 11: Archiving* Scope and Implementation of Part 11: Audit Trails* Standards for Clinical Data SubmissionsCATEGORY — Generics* Bioequivalence Studies With Clinical Endpoints for Vaginal Antifungal Drug Products* Chemistry, Manufacturing, and Controls Documentation Unique to Radiopharmaceuticals Submitted in ANDAs* Generic Drug Labeling When Pediatric Labeling Information Has Been Added to the Innovator LabelingCATEGORY – Good Review Practices* General Clinical Review TemplateCATEGORY — IND* Consumer Product Safety Commission – Tamper Resistant Packaging for INDs* Pediatric Safety and Efficacy Data in INDsCATEGORY — Labeling* Content and Format of the Clinical Pharmacology Section* Content and Format of the Warnings and Precautions, Contraindications, and Boxed Warning Sections of Prescription Drug Labeling* Drug Names and Dosage Forms* Pregnancy Labeling Revisions* Submitting Proprietary Names for EvaluationCATEGORY — OTC* Actual Use Trials* Labeling Comprehension Studies for OTC Drug Products* Labeling for Over-The-Counter Human Drug Products* Labeling Over-The-Counter Human Drug Products; Questions and Answers* Time and Extent ApplicationsCATEGORY — PDUFA III* Continuous Marketing Application: Pilot 1 – Discipline Review Letters for Pre-Submitted "Reviewable Units" of NDAs/BLAs* Continuous Marketing Application: Pilot 2 – Frequent Scientific Feedback and Interactions During Drug Development* Good Review Management PrinciplesCATEGORY — Pharmacology/Toxicology* Drug-Induced Vasculitis in Nonclinical Studies* Estimating the Safe Starting Dose for Clinical Trials of Therapeutics in Adult Healthy Volunteers* Immunotoxicology Evaluation of Investigational New Drugs* Nonclinical Safety Evaluation of Pediatric Drug Products* Nonclinical Studies for Development of Pharmaceutical ExcipientsCATEGORY — Procedural* Assessment of Abuse Potential of Drugs* Dispute Resolution Involving Pediatric Labeling* Exocrine Pancreatic Insufficiency Drug Products - New Drug Application Requirements* Process for Contracts and Written Requests Under the Best Pharmaceuticals for Children Act* Qualifying for Pediatric Exclusivity Under Section 505a of the Federal Food, Drug, And Cosmetic Act* Reports on the Status of Postmarketing Studies -- Implementation of Section 130 of FDAMA
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.