Aktualności
FDA: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
20.07.2016
For a drug product compounded by an outsourcing facility to qualify for the exemptions under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), it must not be
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FDA: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
20.07.2016
To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a drug product must be compounded by a licensed pharmacist or physician who does not
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FDA: Bacterial Vaginosis: Developing Drugs for Treatment
20.07.2016
The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for the treatment of bacterial vaginosis (BV). This draft
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RAPS: Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents
20.07.2016
Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s
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RAPS: FDA to Drug Compounders: Inspection Changes Coming in August
20.07.2016
The US Food and Drug Administration (FDA) on Tuesday announced major changes with respect to inspections of drug compounders as infections linked to poor quality drugs continue to crop up. ...
RAPS: Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US
20.07.2016
The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they
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RAPS: EMA and FDA Begin Collaborations on Patient Engagement
30.06.2016
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development,
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RAPS: FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes
30.06.2016
The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit
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FDA: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
30.06.2016
This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance is applicable to all INDs of LBPs, whether clinical
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FDA: Elemental Impurities in Drug Products Guidance for Industry
30.06.2016
This draft guidance provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with implementation of International
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