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April 23, 2013

  1. FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain (4/23/2014)
     
  2. MedWatch Safety Alert: Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates (4/23/2014)
     
  1. FDA Communication with States (4/22/2014)
    1. Inter-governmental Working Meeting on Pharmacy Compounding, March 20-21, 2014
    2. Outsourcing Facilities
       
  2. Manual of Policies and Procedures (MAPP)  5015.8 Acceptance Criteria for Residual Solvents (PDF - 36KB) (4/22/2014)
     
  3. Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 89KB) (4/22/2014)
     
  1. MedWatch Safety Alert: Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates (4/21/2014)
     
  2. MedWatch Safety Alert: Cubicin (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter (4/21/2014)
     
  3. Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics, May 19-20, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information (4/21/2014)
     
  4. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October – December 2013 (4/21/2014)
     

April 16, 2014

  1. New Safety Measures Announced for Extended-release and Long-acting Opioids (updated 4/16/2014)
     
  2. Public Notification: S.W.A.G Contains Hidden Drug Ingredient (4/16/2014)
     
  3. Guidance for Industry (updated 4/16/2014):
    1. Comprehensive List of Guidance Documents (PDF - 846KB)
    2. New/Revised Withdrawn List for 2014 (PDF - 66KB)
       
  4. Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research (updated 4/16/2014)
     

April 15, 2014

  1. National Drug Code Directory (4/15/2014)
     

April 11, 2014

  1. FDA Drug Safety Podcast: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension (4/11/2014)
     
  1. Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction. June 9, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503, Silver Spring, MD.  Meeting Information (4/9/2014)
     
  1. Guidance for Industry: Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs (PDF - 135KB) (Updated 4/8/2014)
     
  2. Meeting Presentation: Value of a Qualified Clinical Outcome Measure (PDF - 426KB) (4/8/2014)
     

April 3, 2014

  1. Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.” The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients.  Meeting Information (4/3/2014)
     

April 2, 2014

  1. Public Notification: New You Contains Hidden Drug Ingredients (4/2/2014)
     

April 1, 2014

  1. FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension (4/1/2014)
     
  2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (Updated 4/1/2014)
     

March 31, 2014

  1. Draft Guidance: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act (PDF - 185KB) (Updated 3/31/2014)
     
  2. FDA approves Topamax for migraine prevention in adolescents (3/31/2014)
     
  3. FDA Drug Safety Communication: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension (3/31/2014)
     

March 28, 2014

  1. Medication Guide (Updated 3/28/2014)
     
  2. Approved Risk Evaluation and Mitigation Strategies (REMS) (Updated 3/28/2014)
     
  3. Exceptions and Alternative Procedures Approved Under 21 CFR 640.120  (Updated 3/28/2014)
     

March 27, 2014

  1. Alzheimer's Disease Regulatory Science Fellowship (3/27/2014)
     
  2. CDER Data Standards Program (Updated 3/27/2014)
     

March 26, 2014

  1. Acetaminophen Information (Updated 3/26/2014)
    1. All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing
       

March 25, 2014

  1. FDA study findings could facilitate development of safe artificial blood (Posted: 3/25/2014)
     
  2. Guidance for Industry and Food and Drug Administration Staff: Premarket Assessment of Pediatric Medical Devices (Posted: 3/25/2014)
     
  3. Federal Register Proposed Rule: Medical Device Classification Procedures-DOC # 2014-06364 (Posted: 3/25/204)
     
  4. Current Drug Shortages Index (Updated 3/25/2014)
     
  5. Expanded Access INDs and Protocols (Reports) (/25/2014)
     

March 24, 2014

  1. Guidance for Industry: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (PDF - 170KB) (Updated 3/24/2014)
     

March 19, 2014

  1. Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient (3/19/2014)
     

March 18, 2014

  1. National Drug Code Directory (Updated 3/18/2014)
     
  2. Orange Book Data Files (compressed) - February 2014 (ZIP - 570KB) (Updated 3/18/2014)
     
  3. Paragraph IV Patent Certifications (Updated 3/18/2014)
     

March 17, 2014

  1. MedWatch Safety Alert: VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter (3/17/2014)
     
  2. Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (PDF - 805KB) (Updated 3/17/2014)
     

March 13, 2014

  1. Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF-74KB) (3/13/2014)
     

March 12, 2014

PharmCast Research Store
  1. CDER Export Certificate Program Frequently Asked Questions (FAQs) (PDF - 39KB) (3/12/2014)
     

March 11, 2014

Pharm/Biotech Licensing
  1. ANDA Forms and Submission Requirements (updated 3/12/2014)
     
  2. FDA Drug Safety Podcast: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia (3/11/2014)
     
  3. Generic Drugs: Information for Industry (updated 3/12/2014)
     
  4. Meeting Presentation: FDA Regulation of Controlled Substances (PDF - 429KB) (3/11/2014)
     
  5. Questions and Answers: Changes to the Indicated Population for Miacalcin (calcitonin-salmon) (3/11/2014)
     
  6. Spanish FDA Drug Safety Communication: Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba cambios en la etiqueta del medicamento antibacteriano Doribax (doripenem) detallando el incremento en el riesgo de muerte en pacientes con pulmonía en respirador (3/11/2014)
     

March 10, 2014

Free Pharm/Biotech Magazine Subscription
  1. Guidance for Industry: Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment (PDF - 337KB) (3/10/2014)
     

March 7, 2014

Free Pharm/Biotech Magazine Subscription
  1. MedWatch Safety Alert:  MedDIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold (3/7/2014)
     
  2. MedWatch Safety Alert: Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules (3/7/2014)
     

March 6, 2014

Web Seminars -- Pharm/Biotech/etc.
  1. FDA Drug Safety Communication: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia (3/6/2014)
     
  2. FDA Drug Statement: FDA-EMA extends pilot program of the QbD parallel-assessment (3/6/2014)
     

March 4, 2014

Pharm/Biotech Jobs
  1. Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (PDF - 106KB) (3/4/2014)
     

March 3, 2014

Pharm/Biotech Resources
  1. Unfortunately, due to the extraordinary weather circumstances in the DC metropolitan area the ADEPT workshop scheduled for Tuesday, March 4, 2014 in Bethesda, MD, is postponed indefinitely. For more information, please see Meeting Information (3/3/2014)
     
  2. DDI Webinar - Safe Use Initiative, Collaborating to Reduce Preventable Harm.– March 24, 2014 (3/3/2014)
     
  3. Drug Safety Oversight Board Meetings: Public Summaries (3/3/2014)

February 28, 2014

Training Courses -- Pharm/Biotech/etc.
  1. Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices (Revised Draft Guidance) (PDF - 150KB) (updated 2/28/2014)
     

February 27, 2014

Pharm. Operation & Laboratory Software
  1. Guidance for Industry: Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance (PDF - 167KB) (updated 2/27/2014)
     

February 26, 2014

PharmCast Research Store
  1. FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files (updated 2/26/2014)
     

February 25, 2014

Pharm/Biotech Licensing
  1. FDA approves Myalept (metreleptin for injection) to treat rare metabolic disease (2/25/2014)
     

February 24, 2014

Free Pharm/Biotech Magazine Subscription
  1. Manual of Policies and Procedures (MAPP) 4658.3 Rev.1 Requesting New Full-Time Equivalents (PDF -135 KB) (2/24/2014)
     

February 21, 2014

Web Seminars -- Pharm/Biotech/etc.
  1. Guidance for Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (PDF - 248KB) (2/21/2014)
     
  2. Food and Drug Administration/Xavier University PharmaLink Conference—Leadership in a Global Supply Chain, March 19, 2014 and March 21, 2014, Xavier University, 3800 Victory Pkwy.,Cincinnati, OH 45207. Meeting information (2/21/2014)
     
  3. Over-The-Counter Drug Monograph System - Past, Present and Future; Public Hearing,  March 25-26, 2014, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503 (Great Room), Silver Spring, MD. Meeting information (2/21/2014)
     

February 20, 2014

George Washington University's Healthcare MBA
  1. Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments, May 28-29, 2014, FDA White Oak Campus, Bldg. 31, The Great Room (Rm. 1503), Silver Spring, MD. Meeting information (2/20/2014)
     

February 19, 2014

Pharm/Biotech Jobs
  1. From a Clinical Perspective: Drug development guidelines for Hepatitis C virus (2/19/2014)
     
  2. Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 359KB) (Updated 2/19/2014)
     
  3. FDA approves Northera (droxidopa) to treat neurogenic orthostatic hypotension (2/19/2014)


 

   

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