Join Lachman Consultants at this year’s FDLI Annual Conference in Washington, DC, May 17 –18, 2023, for a two-day hybrid event that will address complex legal, regulatory, compliance, and policy issues in all facets of the FDA-regulated industry. Lachman Consultants will be represented by: Martin Shimer (Executive Director) Rachel Thompson, JD (Senior Director) David Petshaft, […]
Coming off the March total of 117 (ninety‑six full approvals and twenty‑one tentative approvals), April’s numbers are good but fall short of any big records. April saw the OGD unofficially issue sixty‑four full‑approval actions and eleven tentative‑approval actions for a total of seventy‑five approval actions. If these figures hold firm when the official numbers are […]
Being proactive is always better than being reactive. And when it comes to a possible “visit” from FDA, anticipation and preparation go a long way in lowering anxiety and navigating the process successfully. Knock, knock. When an FDA investigator walks into your facility informing that they are going to conduct an inspection, a tense moment […]
Many companies are always on the lookout for in‑licensing opportunities and/or product acquisitions to boost their product portfolio or to quickly fill voids in their development program. Given the cost outlay for such opportunities and their associated risks, it is imperative that due diligence of these new potential assets is performed by qualified individuals who […]
FDA has warned consumers not to use two products containing ammonia chloride, “Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.” The Agency says, “Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction” and it “has received reports of adverse events […]
Today we address what might seem like an ongoing problem with no end. I refer to the submission of unsolicited amendments by DMF holders during an ANDA review cycle. If the DMF holder is unaware of the status of an ANDA and they do submit an unsolicited amendment, it could delay the review cycle or […]
The PDA Annual Meeting was held in New Orleans on April 3-5, 2023. It was a great conference with the theme of “Back to the Future: Learning from the Past in a Patient‑Centric World.” The plenary and breakout sessions truly held to that theme. The first plenary session started off with a discussion of Rare Diseases […]
March 2023 was an outstanding month for approval actions, with OGD unofficially issuing 123 total approval actions comprised of 95 full approval actions and 18 tentative approval actions. There were other months with 100 or more total approval actions, but we have not seen that level of approval productivity in a while. The record of […]
On Monday, the FDA announced a change to the REMS for opioids to include a requirement “to make prepaid mail‑back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.” As part of the new, revised REMS requirement, “all manufacturers of opioid analgesics used in outpatient settings are […]
Emergent Bio Solutions received FDA approval today to market an over the counter (OTC) 4mg nasal spray to reverse opioid overdose. What does that mean to the public and the industry? For the public, as soon as the company begins distributing the product, it means easy access to a potentially lifesaving emergency medication to treat […]
