January 2018

30
Jan

Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA). A new tactic that has been recently used by a generic firm to protect its […]

Read More
26
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan (Part II)

Just days after FDA Commissioner Dr. Scott Gottlieb shared the 2018 Compounding Policy Priorities Plan, FDA issued three guidances: (1) Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act   ; (2) Compounded Drug Products That Are Essentially Copies of Approved Drug […]

Read More
23
Jan
Bending, Breaking or Moving On Image

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety […]

Read More
19
Jan
Future Green Road Sign Over Dramatic Clouds and Sky.

Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see […]

Read More
12
Jan

From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says – article in Medtech Insight by Lachman Consultants

Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – […]

Read More
12
Jan
Elderly stylish attractive blond woman coughing or sneezing into her hand as she stands on a rural lane on a misty winter day

No More Pediatric Labeling for Codeine or Hydrocodone Cough Syrups

The FDA announced today that they are revising labeling to remove any indication for codeine or hydrocodone-containing cough cold products for use in patient under the age of 18. The FDA Safety Communication (here) states: “We are taking this action after conducting an extensive review and convening a panel of outside experts.  Both of these […]

Read More
1 2