ICH Q7 cGMPs for APIs Q&A Guidance Issues

Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.”  FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document.

The Q&A document referenced above responds to those questions. 

Got Some Time on Your Hands – New Quality Guidance for MDIs and DPIs Issues

On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”.  The original guidance was published November 13, 1998.  The revision spans some 50 pages of discussion about critical quality attributes,

Paragraph IV Certifications Last 4 Plus Years

Almost everyone in the generics industry is familiar with the FDA Paragraph IV database (aka list).  As described by the Agency, the list is published “[a]s part of its ongoing efforts to assist generic drug applicants in preparing their applications, FDA regularly publishes a list of drug products for which an ANDA has been received by the Office of Generic Drugs (OGD) containing a Paragraph IV patent certification.

So How is that Prescription Drug Imported On-line from Canada?

With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate.  While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea.  ABC News (here) seem to validate my opposition.

FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions

We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or liquid caffeine containing products.

New Grant Applications Sought for Topical Products

The FDA has struggled with the best methods to determine the bioequivalence of topical dermatological drug products for years. For example, FDA considered numerous methods including transepidermal water loss (TEWL), skin stripping, and others to demonstrate the bioequivalence of retinoid acne products.  None were found acceptable and the Agency ultimately relied on bioequivalence studies with clinical endpoints to approved generic versions of these cream,

Outsourcing Facilities Make the News Again

On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here).  Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency.  Today’s announcement highlights a continued sterility assurance concern by the FDA.

Approvals Spring Back to Life in Spring – A Look at March and Other Statistics

OGD just released its March 2018 ANDA Approvals and receipts data.  The results are even stronger than reported earlier (here).  March officially saw 56 full approvals and 11 tentative approvals, a few more than we saw on April 3rd, as the databases became fully populated over the next few days.  None of the approvals or tentative approvals were reported as first cycle approvals in the March report.

March Shows More OGD Approval Recovery from the EI Issue

March approvals appear to be moving in the right direction as firms, apparently, are catching up with elemental impurity issues and their amendments are working their way through the review and approval process.  Unofficial March ANDA approval numbers taken from the Recent New and Generic Drug Approvals list (here) show 50 full approvals and 10 tentative approvals. 

FDA Acts to Remove the Rx Status of PEG 3350

It has been just about 11.5 years since FDA approved an OTC version of MiraLAX and the innovator withdrew the Rx-labeled NDA product from the market.  Why did it take this long?  Other than the fact that ANDAs approved prior to the approval of the OTC version were making significant profits, there were differences between how the ANDA applicants and the FDA viewed the change in labeling.

4 New Paragraph IV Certifications Listed by FDA

Everyone associated with generic drug submission realizes that generic companies that want to market a copy of a drug product prior to the expiration of a patent must file a patent challenge to existing patents (a so-called Paragraph IV [“PIV”] challenge).  FDA updates its list of PIV submissions so other firms will know the date of a first filer. 

Median Actions on Inspections Reported By FDA

Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has recently issued and the full report can be found here.

Coming around the Home Stretch, Heading for the Finish Line – It’s China by a Nose?

Despite being the co-leader and taking the number one or two spots in Warning Letters received with India for the last few years, China had made great strides in obtaining ANDA approvals.   According to an article by Jin Zhang M.D., Ph.D, on PharmaExec.com (here), Chinese firms received 38 ANDA approvals in 2017 (that is 5% of all approvals for the for FY 2017),