Bob Pollock, Author at Lachman Consultants

Biosimilar Interchangeability Guidance Hits the Street

By Bob Pollock | May 10, 2019 | Biologics, BLA, FDA, Regulatory Affairs, Science & Technology | Like |

The issue of the use of biosimilars and their uptake in the market has been a discussion point since the first biosimilar was approved in 2015. Today, the FDA issued a long-awaited guidance on how a firm can demonstrate interchangeability of a biosimilar to its reference licensed product. The guidance is titled Considerations in Demonstrating Interchangeability With a Reference Product (which is a bit confusing as it applies only to biosimilars) and can be found here.

505(j) or 505(b)(2) – What’s Your Poison?

By Bob Pollock | May 9, 2019 | ANDAs, FDA, Generics, NDA, Regulatory Affairs | Like |

Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)). We first blogged about this here. The selection of the type of application to submit has been a source of discussion ever since the Hatch-Waxman Act of 1984 created the 505(b)(2) process,

April 2019 Approval Actions Top the 100 Mark Again

By Bob Pollock | May 3, 2019 | ANDAs, Approvals, FDA, Generics, Regulatory Affairs | Like |

So far this FY, total approval actions (note that we are no longer saying approvals) have topped 100 each and every month, from a high of 132 (note that that figure was originally reported as 128, before FDA implemented its revised approval action counting reporting method (see previous post here). While the official April numbers are not out yet,

Consumer Antiseptic Rubs Final Rule – or Is It?

By Bob Pollock | April 11, 2019 | FDA, OTC | Like |

Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies and the Agency has time to review the additional information to be submitted.

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Pediatric Labeling Information Road Map Provides Good Directions

By Bob Pollock | March 27, 2019 | FDA, NDA, Regulatory Affairs | Like |

This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive.

ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)

By Bob Pollock | March 26, 2019 | ANDAs, FDA, Generics, NDA, Regulatory Affairs | 3 |

Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.

High Priority - Business or Marketing Mode Concept. 3D

FDA Prioritizes ANDA for Valsartan to Avert Shortage

By Bob Pollock | March 13, 2019 | ANDAs, FDA, Generics, Regulatory Affairs | 1 |

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.” The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.

Compounder of Sterile Products Hit with Consent Decree

By Bob Pollock | March 12, 2019 | Compliance, Compounding, FDA | Like |

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas. According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products. “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.

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First Time Generic Approvals January to March 8, 2019

By Bob Pollock | March 11, 2019 | ANDAs, FDA, Generics, Regulatory Affairs | Like |

Each year, the OGD publishes a list of first-time generic approvals, which are defined by the agency as:

“First generics” are just what they sound like—the first approval by the FDA which permits a manufacturer to market a generic drug product in the United States. The FDA considers first generics to be important to public health and prioritizes review of these submissions.

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Whoops! February Approval Actions at 99 or 106! But Don’t Be Fooled by the Numbers – Plus January Stat Update

By Bob Pollock | March 8, 2019 | ANDAs, Approvals, FDA, Generics, Regulatory Affairs | 1 |

Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really? Don’t know exactly how that happened because our estimates are usually below the totals. Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals.

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Commissioner Gottlieb Resigns – A Blow to the FDA and the Health of the Nation

By Bob Pollock | March 5, 2019 | Compliance, FDA, Generics, Medical Devices, New Drugs | 10 |

In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his taxing weekly commute to Bethesda/D.C.

Final Guidance on Bulk Drugs that Can Be Used for Compounding for 503B Outsourcing Facilities

By Bob Pollock | March 1, 2019 | Compliance, Compounding, FDA, Regulatory Affairs | Like |

The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty comments from stakeholders and,

The ANDA January and December Receipt Debate Answered Today by Report Update

By Bob Pollock | February 20, 2019 | ANDAs, FDA, Generics, Regulatory Affairs | 1 |

Much like all we do at tax time, we look for anything that might lower our taxes. We look for deductions, charitable gifts, donations, business expenses and do a lot of hope and praying. Well, FDA had a corollary situation when they were looking at how to count and where to place ANDAs in the submission queue,

Day Two at AAM Annual Meeting – The Big Guns Come out

By Bob Pollock | February 6, 2019 | ANDAs, Biologics, FDA, Generics, NDA, Regulatory Affairs | 2 |

Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman.

Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics. This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space.

January Shutdown Could not Stop 100+ Approval Actions

By Bob Pollock | February 4, 2019 | ANDAs, FDA, Generics, Regulatory Affairs | 1 |

Even with the 35-day government shutdown and the stress that came with it, it appears that OGD has broken the 100 approval action barrier again with what looks like (so far) 102 approval actions posted for January as of February 4th. The data is taken from the FDA All Approvals list here .

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Author Archive: Bob Pollock