Microsoft Word - 5320.1.doc
...Description of the Composition of the Drug Product..Description of the drug product composition.....References to the corresponding drug product..sections of the CTD-Q and a reference to the ICH.....Description of the manufacturing process for the drug product, including..sterilization..
http://www.fda.gov/cder/mapp/5320.1.pdf (score=100)

FDA Enforcement Report
...CHARGE The defendants are permanently enjoined from the interstate shipment of any drug.....PRODUCT Health for Life brand L-Carnitine, 250 mg Caplets, in bottles of 30, nutritional.....REASON Blood product untested for viral markers was distributed for further manufacture..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00238.html (score=100)

...This applies to any material where such procedures are necessary, including drug substance, drug product.....Establishing a new procedure for reprocessing a batch of drug substance or drug product that fails to meet the.....A change in methods or controls that provides increased assurance that the drug substance or drug product will..
http://www.fda.gov/cder/guidance/3516fnl.doc (score=100)

...Sponsors should study a number of separate product lots during drug development to demonstrate that a safe and.....Murine retrovirus testing of the final product is needed on the final-filled product only when the antibody is produced in a.....Department of Health and Human Services Food and Drug Administration Center for Biologics..
http://www.fda.gov/cber/gdlns/ptc_mab.txt (score=100)

Therapeutic Equivalence of Generic Drugs Letter
...FDA works with both brand-name and generic drug product manufacturers after a drug product is in the marketplace to assure its.....For example, brand-name and generic drug product manufacturers may want to change the drug.....In approving a generic drug product, the FDA requires many rigorous tests and procedures to..
http://www.fda.gov/cder/news/nightgenlett.htm (score=100)

Combating Counterfeit Drugs: A Report of the Food and Drug Administration
...This unique number would allow each drug purchaser to immediately determine a drug's authenticity, where it was intended for sale.....FDA is working with RFID product developers, sponsors, and participants of RFID.....drug distribution system, about counterfeit drug incidents in a timely manner and educating these parties on ways to identify and..
http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html (score=100)

/a//content.14082
...changes that have occurred in science, Food and Drug Administration.. to represent the.....within a biological product.. Drug, and Cosmetic Act and the Public.. blood industry.....license for a biological product to be.. firms that have more than one.. and to be..
http://www.fda.gov/cber/genadmin/resphead.pdf (score=100)

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...substance obtained from the synthesis and purification procedure is collected in the drug.....The specific procedures used in the formulation and preparation of our finished drug product.....from the finished drug product container and how it is distributed among individual tests is..
http://www.fda.gov/cder/guidance/cmcsample.pdf (score=100)

FDA Enforcement Report
...PRODUCT Drug of Abuse Control CON-DOA Level 1, used in the measurement of the level of drugs in.....PRODUCT Wilcox Dairy brand Pistachio Ice Cream packaged in quart and half gallon.....The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00450.html (score=100)

Guidance for Industry: Postmarketing Safety Reporting for Human Drugs and...
...If two or more companies that co-market a specific drug product have an approved NDA for the.....is any undesirable event that is associated with the use of a drug or biological product in humans whether or.....The current FDA-approved labeling for the human drug or biological product should be used as the reference..
http://www.fda.gov/cber/gdlns/safety031201.htm (score=100)

ICH: Guidance on Specifications: Test Procedures and Acceptance Criteria for...
...Cell substrate-derived, employed will vary from product to product, structure of the carbohydrate.....either the drug substance or drug product. product, which may occur during storage, a drug substance should be.....procedures and acceptance criteria which, stability of drug substance and drug product. A qualitative statement..
http://www.fda.gov/cber/gdlns/ichtest.pdf (score=100)

pike03.PDF
...drug products exported to their Edward Miracco is a consumer safety officer in the Office.....academia and CDER expressed strong support for the Product.. agreement on issues of.....progress and innovative developments in drug research. development and global registration..
http://www.fda.gov/cder/pike/march98.pdf (score=100)

Supplements and Other Changes to an Approved Application; Final Rule
...In addition, as a result of comments requesting that the use of the terms drug, drug product, drug.....For example, a batch of drug product tested using the standard drug product sterility test described in the USP/NF will fail the.....The comments said that to include items beyond the drug substance and drug product represents a level of..
http://www.fda.gov/cber/rules/suppapp.htm (score=100)

MedWatch - Medical Product Safety Information
...product problems that occur after the administration of approved drug and therapeutic.....product safety alerts, Class I recalls, market withdrawals, public health advisories.....Drug Information Questions and Comments.. Division of Drug Information, 301-827-4570..
http://www.fda.gov/medwatch/safety.htm (score=52)

FDA Recalls, Market Withdrawals and Safety Alerts
...This list includes the most significant product actions of the last 60 days, based on the.....Packages of Van De Kamp Cinnamon Rolls (March 14, 2005) Drug Labeling Safety Information.....Issues Allergy Alert on Undeclared Sulfites in Product (May 4, 2005) Edwards Fine Foods..
http://www.fda.gov/opacom/7alerts.html (score=42)

Recalls, Market Withdrawals and Safety Alerts Archive
...Customs Service and Food and Drug Administration Uncover Dumping Scheme Involving.....This archive includes the most significant product actions, based on the extent of.....December 19, 2003) Hansen Beverage Company Issues a Safety Alert and Product Recall of its..
http://www.fda.gov/oc/po/firmrecalls/archive.html (score=38)

Office of Women's Health--Information for Manufacturers
...Find recent product/drug recalls.. Read FDA guidance documents.. Read FDA news releases.. Get the..
http://www.fda.gov/womens/info-manufacturers.html (score=385)

Office of Women's Health--Information for Health Care Practitioners
...Recent product/drug recalls and safety alerts.. FDA information just for health.....Medical product safety information.. FDA news releases on Women's Health.. The Office of.....product and drug recalls, and much more. The latest FDA news and new approvals..
http://www.fda.gov/womens/info-health.html (score=314)

Drugs@FDA: Glossary of Terms
...Once approved, an applicant may manufacture and market the generic drug product to provide a.....The approval history is a chronological list of all FDA actions involving one drug product.....Before approving a generic drug product, FDA requires many rigorous tests and procedures to..
http://www.fda.gov/cder/drugsatfda/glossary.htm (score=174)

CDER Frequently Asked Questions
...A generic drug is a drug product that is equivalent to brand name products in terms of quality and.....Prescription medicines include any drug product that requires a doctor's authorization to.....Before approving a generic drug product, CDER requires many rigorous tests and procedures to..
http://www.fda.gov/cder/about/faq/default.htm (score=174)

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