GXP Data Flow and Security – FDA’s Looking for Sure!

It’s late, do you know where your data is?  Are you really sure?  Would you be able to assure a regulatory agency that you fully understand and control the flow of data from data generation through processing, reporting, data review, archive and retrieval?  If the answer to all the above questions is yes, congratulations!  Unfortunately,

Hey, Wait a Minute Here! Are the UFAs in Danger?

Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews.  Am I seeing this correctly?  Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs negotiated for reauthorization and at the 11th hour,

BE Recommendation Revision Again Demonstrates OGD Recognition of Q1 and Q2 Value

OGD has revised its bioequivalence (BE) recommendation for rifaximin 200 mg and 550 mg tablets. Quite interestingly, the requirements for products that are qualitatively and quantitatively (Q1 & Q2) the same as the reference listed drug (RLD) will have a reduced burden and may eliminate conducting bioequivalence studies with clinical endpoints (albeit pharmacokinetic [PK] studies and in vitro testing will still be needed).

Abuse Deterrent Products – The Debate Continues


We don’t like to mention specific products in this blog, so let’s just say an FDA panel yesterday gave a less-than-stellar review of the benefits of an abuse deterrent product by stating that the benefits of a firms’ long-acting opioid pain reliever no longer outweighed its risk. A crushing blow to the product for certain. 

Challenges and Advantages of International Regulatory Inspections, by Dan Barreto, VP, Compliance

Every year, FDA and key worldwide regulatory authorities perform foreign inspections of production facilities around the world. All inspections share a common goal: to ensure the products shipped to their respective countries will comply with the core requirements for safety, efficacy, quality, purity, and regulatory commitments. While foreign regulatory agencies merit respect, the FDA and U.S.

Cost and Approvals – A Give and Take

Almost every health-related headline today mentions costs.  Whether it be cost of health insurance, cost of hospital stays, doctor’s charges, and (of course) cost of drugs.  While there are some shockers out there for drug costs, most are in line with expectations.  One of the big problems is that even moderately priced drugs are most expensive if they are not taken,

Backlog vs. Workload – Why All the Ruckus

Irritation has been building between the Office of Generic Drugs (OGD) and industry over the use of the terms backlog vs. workload, particularly over the last few months.  At the recent Annual Meeting of the Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association (GPhA), the semantics pot almost boiled over.  So why the big debate over the term describing the number of ANDAs OGD has in its court,