FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling. Interoperability of devices […]

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older. A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels. GSK […]

A Tour of the FDA 2017

A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA […]

Rule relating to orphan drugs in Japan

Orphan drugs are those that are developed purely to treat rare diseases. The nature of orphan drugs is a little piquant: on the one hand, rare diseases affect very few people, but these cannot be ignored. On the other hand, orphan drugs, since they are so few in number, are not taken up usually by […]

USP method transfer

USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012. How is the new document different? The US Pharmacopoeia had earlier issued the 1224 stimuli document in response […]

USP 1058 analytical instrument qualification

USP 1058 analytical instrument qualification is about ensuring that an instrument is suitable for its intended use and application. While system suitability and method validation activities have specific guidelines and procedures; analytical instrument qualification is not so specific. There are conflicting opinions and viewpoints regarding USP 1058 analytical instrument qualification. Though subjective, analytical instrument qualification […]

Sterilization

In lay terms, sterilization is understood in a number of ways. We have sterilization in economics, in family planning and in many other fields. When it comes to this term as used by the FDA; there is a specific purpose and definition. For the FDA, sterilization process controls are indispensable for validation. Sterilization is part […]

Q7 guidelines

Q7 guidelines are those guidelines issued by the ICH (International Conference on Harmonization) in relation to Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API). Q7 guidelines are very comprehensive More than 12 years after they were mooted in November 2000; Q7 guidelines continue to be the driving force for API GMP regulations around the […]

Method transfer FDA

A method transfer is the process of qualifying a laboratory regarding its ability to carry out an analytical test procedure. For method transfer, FDA has some regulations that are simple on the face of it, but require many steps and precautions. Not being in compliance with these steps could invite investigation and corrective measures to […]