April 2018

26
Apr

Mixing Apples and Oranges – Not Sure That the Tactic Works

While reading a commentary today in Investor’s Business Daily (here) written by Peter Pitts, a former FDA Associate Commissioner, I became confused.  The article’s focus was on two pieces of legislation (Creating and Restoring Equal Access to Equivalent Samples [CREATES] Act and the House’s Fair Access for Safe and Timely [FAST] Generics Act) and Mr. […]

Read More
23
Apr
people hand holding analog stopwatch illustration

MaPP 5310.3 on Expedited Review of PAS Supplements for NDAs and BLAs Tracks the Generic Process

The Office of Pharmaceutical Quality (OPQ) today published a Manual of Policy and Procedures (MaPP) document titled Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (here) for new drug applications and biologic license application holder that submit a prior approval supplement […]

Read More
20
Apr
Hanging word Q&A

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.  […]

Read More
19
Apr
Analog clock with the time 11 o'clock

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On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for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 […]

Read More
18
Apr
Gavel next to gears and mechanical diagram for patent application. Concept for patent attorney

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 […]

Read More
17
Apr
Hand holding tablet is pressing button on touch screen interface in front Logistics Industrial Container Cargo freight ship

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 […]

Read More
16
Apr
Lightning bolt set. Grunge strike icon. Power sign. Thunderbolt

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 […]

Read More
13
Apr
Chryotherapy used to Removed an Aged Spot

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 […]

Read More
12
Apr
Outsourcing Facilities Make the News Again Image

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. This latest […]

Read More
1 2