ANDA Supplements Spike in April

The Office of Generic Drugs (ODG) saw the largest number of changes being effected (CBE) supplements (618) as well the largest number of prior approval supplements (PAS) (57) so far, this fiscal year. While these numbers did not break any previous records (678 CBEs in September 2016 and 71 PAS in August 2016) they certainly show a spike from past months in FY 2017.

Happy Holidays from All of Us at Lachman

I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again.  This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you who don’t know what I am talking about – you are too young,

You Learn Something New Every Day!

The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me.  Turns out that, if you are an ANDA applicant and you file with a paragraph IV certification and you are not sued or if your suit is dismissed,

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products.  What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS).  Running applications in the cloud is a relatively new concept for many industries,

Sit! – Stay! – No IND Needed as Part of Guidance Document is Stayed

Last Friday, FDA published a Notice in the Federal Register (here) relative to staying a portion of its September 2013 Guidance Document titled Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.  The Agency indicated that, based on comment received on various sections of the final Guidance,

To Compound or Not to Compound? That is the Question!

To Compound or Not to Compound? That is the Question!

FDA has issued two guidance documents today (here) and (here) that outline the FDA’s interim enforcement policy relative to the use of bulk drug substances in outsourcing facilities and/or pharmacy compounding. The Agency identifies the historical evolution of the list of bulk drug substances acceptable for use in the compounding of drug products and has described its interim enforcement policy regarding drugs compounded under Section 505 A (dealing with pharmacy compounding) and Section 503 B (dealing with outsourcing facilities) of the Federal Food Drug and Cosmetic Act.

GDUFA Fees Announced for FY 2016 – Surprise, Surprise!

The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises.  For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due to the lower number of ANDAs that have been submitted so far in 2015 (377 through June 2015 with a straight line projection at that rate of 502 to be submitted in FY 2015).

Uhl Named Permanent OGD Director

In what was a long-anticipated action, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) announced that Dr. Kathleen “Cook” Uhl will take over the reigns of the Office of Generic Drugs (OGD) on a permanent basis.