The Lachman Blog

11
Jun

Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement

Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA).  The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]

Read More
08
Jun

WEBINAR: FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections

Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]

Read More
08
Jun

WEBINAR: FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for and Responding to FDA Virtual Inspections

Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual […]

Read More
08
Jun

Temporary Provisions for Prescription Drug Sample Delivery and Receipt during the COVID-19 Pandemic Public Health Emergency

The FDA issued an immediately effective guidance today titled Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency (here).  This guidance (which will stay in effect until the public health emergency [PHE] is over) will provide additional flexibility for healthcare providers and distributors of record […]

Read More
08
Jun

Data Integrity Issues Still Plague Pharmaceutical Manufacturers – Where’s the Beef?

I know that I have written about this issue multiple times (here and here; also search our blog for other data integrity posts) and I guess it is a holdover from my time at FDA and living through the generic drug scandal of the late 1980s, but, come on now, folks, the FDA’s bark seems […]

Read More
03
Jun
New and Revised Bio Guidances Issued by OGD Image

New and Revised Product Specific Bioequivalence Recommendations List Update

The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations.  FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]

Read More
02
Jun

Additional Guidance on Hand Sanitizer – Preparation, Manufacture and Temporary Compounding: The Bar is Raised

FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency.  The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]

Read More
1 2 3 4 131