FDA Archives - Page 133 of 135 - Lachman Consultant Services, Inc.

Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs – A Simple Idea

By Bob Pollock Sep 17, 2013 FDA Generics Regulatory Affairs

Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required that serious adverse event information be reported to FDA for dietary supplements and OTC drugs not approved through a new drug application. There are many questions that can come up as soon as you dig a little deeper into what is required. Some answers will be provided here, but these are meant only to call attention to the potential complexity and depth of these requirements.

Sep

Long Awaited Advair Bioequivalence Draft Guidance Is Published

By Bob Pollock Sep 10, 2013 FDA Regulatory Affairs

On September 9, 2013, the FDA published a draft guidance designed to provide current agency thinking on the methods and testing necessary to establish bioequivalence between the reference listed drug (RLD) and the generic powder for inhalation.

Sep

FDA Issues Revised Q&A Draft Guidance on GDUFA

By Bob Pollock Sep 10, 2013 FDA Generics Regulatory Affairs

Today, the FDA released Revision 1 to the Draft Guidance to Industry: Generic Drug User Fee Amendment of 2012: Questions and Answers. This 36 page document contains additional questions and answers (as well as clarifications) to some of the issues raised in the original draft guidance issued on August 22, 2012.

Sep

Wait a Minute – Did Everyone Think This One Through?

By Bob Pollock Sep 09, 2013 Compliance FDA Regulatory Affairs

Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks. In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were […]

Sep

FDA Announces BE Draft Guidance for Advair Diskus and Revised Q&A on GDUFA

By Bob Pollock Sep 09, 2013 FDA Generics Regulatory Affairs

The FDA has announced on the Federal Register (FR) prepublication page the availability (tomorrow) and publication of two documents that will be of significant interest to the industry.

Sep

Q&A Document on ANDA Stability Publishes as Draft Guidance

By Bob Pollock Sep 03, 2013 FDA Generics Regulatory Affairs

Today the FDA issued the long awaited Guidance to Industry: ANDAs Stability of Drug Substances and Drug Products in draft answering questions the public submitted relative to the final ANDA stability guidance document issued September 25, 2012.

Sep

Compounding Pharmacies – Do You Notice a Trend Developing?

By Bob Pollock Sep 03, 2013 Compliance FDA Generics Regulatory Affairs

Ever since the meningitis outbreak associated with the products from the New England Compounding Center, the FDA and the States have been taking a closer look at this segment of the industry. So far, in 2013 alone, the FDA has issued 51 Safety Alerts for Human Medical Products, of which 17 (33%) related to sterile pharmacy compounded products and/or laboratories that tested those products for sterility and/or potency. In addition, FDA has taken 54 separate actions against compounding pharmacies in 2013 alone, with only 24 actions taken in the previous 5 years.

Aug

FDA and the EMA (European Medicines Agency) Issue Q&A Document to Communicate Results from Initial QbD Parallel Assessment

By Bob Pollock Aug 22, 2013 Compliance FDA Generics Regulatory Affairs

On August 20, 2013, FDA and the EMA (European Medicines Agency) published a document entitled, “EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: Lessons learnt and Q&A resulting from the first parallel assessment.” The Q&A document provides information regarding agreements that were made between the agencies as a result of the first FDA-EMA parallel […]

Aug

June Approval Times for ANDAs – A Snapshot in Time

By Bob Pollock Aug 19, 2013 FDA Generics Regulatory Affairs

Collecting information about mean and median approval times for abbreviated new drug applications (ANDAs) is very difficult, time consuming and frustrating. We looked at the 31 approvals in June 2013 to see how the Office of Generic Drugs (OGD) was doing.

Aug

Medical Foods Q&A Update – Is FDA Preparing for Action? Is Pregnancy a Disease? What’s Next?

By Bob Pollock Aug 14, 2013 Compliance FDA Generics Regulatory Affairs

Yesterday, the FDA released an update to its 2007 Questions and Answers document on Medical Foods. Interestingly, it is the new information in this document that has us scratching our heads about the implications of this revised draft document.

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FDA

Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs – A Simple Idea

Long Awaited Advair Bioequivalence Draft Guidance Is Published

FDA Issues Revised Q&A Draft Guidance on GDUFA

Wait a Minute – Did Everyone Think This One Through?

FDA Announces BE Draft Guidance for Advair Diskus and Revised Q&A on GDUFA

Q&A Document on ANDA Stability Publishes as Draft Guidance

Compounding Pharmacies – Do You Notice a Trend Developing?

FDA and the EMA (European Medicines Agency) Issue Q&A Document to Communicate Results from Initial QbD Parallel Assessment

June Approval Times for ANDAs – A Snapshot in Time

Medical Foods Q&A Update – Is FDA Preparing for Action? Is Pregnancy a Disease? What’s Next?

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