U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
FDA announces safety changes in labeling for some cholesterol-lowering drugs (Feb 28)
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced by the FDA.
Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen (Feb 27)
Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg), because of a packaging error where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.
Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries (Feb 16)
FDA notified parents, caregivers, consumers, and dental care professionals about reports of serious injuries and potential hazards associated with the use of all models of the Spinbrush.
FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning (Feb 15)
The planned return of CardioGen-82 to the U.S. market follows a voluntary recall by the manufacturer, Bracco Diagnostics, Inc.. FDA has approved revised labeling for CardioGen-82 to include a Boxed Warning and enhanced testing information to help minimize the risk for exposure to unintended levels of strontium radiation.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/Safety/MedWatch
PRODUCT APPROVALS:
FDA approves first Helicobacter pylori breath test for children (Feb 24)
FDA has approved the first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers.
FDA approves Korlym for patients with endogenous Cushing’s syndrome (Feb 17)
Korlym (mifepristone) was approved by FDA to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.
For information on drug approvals, please visit Drugs@FDA
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
FDA announced a public hearing on March 22-23 to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.
Submit either electronic or written requests for oral presentations and comments by March 9, 2012. Either electronic or written comments will be accepted after the hearing until May 7, 2012.
Guidance for Industry: FDA Oversight of PET Drug Products Questions and Answers: Draft Guidance (Feb 24)
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage: Draft Guidance (Feb 21)
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs: Draft Guidance (Feb 13)
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance
Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Draft Guidance: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry: FDA Regulation of PET Drug Products: Draft Guidance (Feb 2)
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Pediatric Medical Devices; Public Workshop; Reopening of Comment Period (Jan 25)
The FDA is reopening the comment period for the notice entitled ``Pediatric Medical Devices; Public Workshop; Request for Comments'' that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463) until March 5, 2012. In the notice, FDA announced a public workshop to consider factors affecting the use of scientific research data to support pediatric medical device efficacy claims.
Comment on Proposed Regulations and Submit Petitions http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm
Submit your comments on many of FDA's proposed regulations
ANNOUNCEMENTS:
FDA reaches $1 million settlement with Pennsylvania medical device firm (Feb 28)
The FDA reached a $1 million civil money penalty settlement with Globus Medical Inc., of Audubon, Pa., for the distribution of unapproved medical devices.
FDA acts to bolster supply of critically needed cancer drugs (Feb 21)
The FDA announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.
On Tuesday, February 21, 2012, FDA held a briefing on drug shortages. A replay of this briefing is available through March 21, 2012, by calling 800-839-8792. For international callers dial 203-369-8792, and enter passcode 24569.
Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.)
Comunicado de la FDA sobre la seguridad de los medicamentos: Importantes interacciones entre el medicamento Victrelis (boceprevir) y los medicamentos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir (Feb 22)
Comunicado de la FDA sobre la seguridad de los medicamentos: La diarrea asociada con Clostridum difficile puede estar relacionada con los medicamentos contra la acidez estomacal denominados inhibidores de la bomba de protones (PPIs por sus siglas en inglés) (Feb 16)
UPCOMING MEETINGS:
FDA Rare Disease Patient Advocacy Day (Mar 1)
Meeting of the Tobacco Products Scientific Advisory Committee (Mar 1 -2)
Meeting of the Arthritis Advisory Committee (Mar 12)
Meeting of the Gastrointestinal Drugs Advisory Committee (Mar 13)
Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Mar 14)
Hepatotoxicity Special Interest Group: Why DILI Idiosyncrasy? The Immune System and Beyond (Mar 14-15)
Meeting of the Oncologic Drugs Advisory Committee (Mar 20)
Meeting of the Oncologic Drugs Advisory Committee (Mar 21)
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs (Mar 22 – 23)
Meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee (Mar 23)Meeting of the Cardiovascular and Renal Drugs Advisory Committee (Mar 27)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Mar 28-29)
Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee (Apr 2)
Meeting of the Reproductive Health Drugs Advisory Committee (Apr 5)
Meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee (Apr 11 – 12)
Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments; Public Workshop (Apr 12)
FDA/Drug Information Association (DIA) Cardiovascular Safety and State-of-the-art Development Issues (Apr 17 – 18)
Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop (May 30-31)
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.
RESOURCES:
Continuing Education
The Clinical Investigator's CME Program: Transforming a Clinician Into an Investigator: What Does It Take?
Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today.
Articles
Please visit Articles of Interest to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.
Videos
MedWatch Safety Information Resources for Busy Physicians
A video discussing Medwatch Safety Alerts
What To Do About Misleading Drug Ads
A video discussing FDA's Bad Ad Program Featuring Michael Sauers, Team Leader for FDAs Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research.
Other Resources
FDA MedWatch Twitter
Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter. Follow us on Twitter to receive the MedWatch Safety Alerts: http://twitter.com/FDAMedWatch
For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.
MedWatch Safety Alerts for Human Medical Products
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
Table of Pharmacogenomic Biomarkers in Drug Labels (Feb 23)
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose.
New and Generic Drug Approvals
Consumer Updates
Timely and easy-to-read articles covering all FDA activities and regulated products
FDA Expands Advice on Statin Risks (Feb 28)
Helping Rare Disease Patients Find Their Voice (Feb 27)
Why Do People Use Tobacco? Looking for Answers (Feb 23)
Grapefruit Juice and Medicine May Not Mix (Feb 23)
Toothbrush Can Chip Teeth and Cause Choking (Feb 16)
FDA Drug Info Rounds
A series of training videos for practicing clinical and community pharmacists.
Device Use Safety Tips
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.
FDA Patient Safety News
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.
FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.
FDA Voice
FDA Voice is the official blog from FDA's senior leadership and staff. FDA Voice is a new forum and through upcoming blog posts you will find news, background, announcements and other information about the work done at the FDA on behalf of the American public.
Hope on the Horizon (Feb 23)
Best regards,
Office of Special Health Issues
Food and Drug Administration
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