While the FDA is step­ping up in­spec­tions of man­u­fac­tur­ing sites af­ter Covid-19 caused de­lays, the reg­u­la­tor has is­sued new guid­ance to the in­dus­try sur­round­ing changes re­gard­ing dis­pos­able ma­te­ri­als.

The guid­ance states that any changes to dis­pos­able ma­te­ri­als used pri­mar­i­ly in drug and bi­o­log­i­cal prod­uct man­u­fac­tur­ing, in­clud­ing at con­tract man­u­fac­tur­ing sites, must “be avail­able up­on re­quest dur­ing an FDA in­spec­tion.”

Man­u­fac­tur­ers are al­so re­quired to doc­u­ment and get ap­provals for changes in both hu­man and an­i­mal drug ad­min­is­tra­tion and all dis­pos­able ma­te­ri­als.

Ac­cord­ing to the FDA, it has re­ceived ques­tions sur­round­ing the lim­it­ed avail­abil­i­ty of dis­pos­able man­u­fac­tur­ing ma­te­ri­als, es­pe­cial­ly when the de­mand in­creas­es around pub­lic health events or nat­ur­al dis­as­ters. The avail­abil­i­ty of dis­pos­able ma­te­ri­als can be­come short, af­fect­ing the pro­duc­tion of drugs and bi­o­log­i­cal prod­ucts.

The reg­u­la­tor rec­om­mends that ap­pli­cants use sci­ence and risk-based prin­ci­ples and re­fer to cur­rent guide­lines for the in­dus­try to de­ter­mine the ap­pro­pri­ate way to com­mu­ni­cate changes to dis­pos­able ma­te­ri­als in the man­u­fac­tur­ing process.

Man­u­fac­tur­ers need to re­port if sup­pli­ers changed and if they’re us­ing sim­i­lar ma­te­ri­als that may dif­fer in com­po­si­tion or de­sign. They must al­so re­port re­duc­tions in the num­ber of ma­te­ri­als used and if reusing dis­pos­able ma­te­ri­als.

The guid­ance de­tails the po­ten­tial risks to prod­uct qual­i­ty for the use of the dis­pos­ables in the man­u­fac­tur­ing process in­clud­ing whether a dis­pos­able ma­te­r­i­al is used up­stream or down­stream, the use of re­dun­dant steps in the process, whether sta­bil­i­ty con­trols meet cur­rent reg­u­la­tions, and the ex­tent of ex­ist­ing val­i­da­tion da­ta.

Man­u­fac­tur­ers are al­so ad­vised to con­sid­er those fac­tors in de­ter­min­ing the risk to prod­uct qual­i­ty for any pro­posed change.

A com­pa­ra­bil­i­ty pro­to­col (CP) could be used al­so for mak­ing changes to dis­pos­ables, ac­cord­ing to the new guide­lines. Ap­pli­cants can use a CP to ob­tain feed­back from FDA on prospec­tive sci­en­tif­ic ap­proach­es sub­mit­ted as part of an orig­i­nal ap­pli­ca­tion to speed up post-ap­proval changes. An ap­proved CP can be used as a one-time change or re­peat­ed­ly for a spec­i­fied type of change over a prod­uct’s life­cy­cle.

When con­tact­ing the FDA about any changes, man­u­fac­tur­ers must pro­vide in­for­ma­tion on the af­fect­ed prod­ucts, any pro­posed changes that could mit­i­gate the ef­fects of the short­age on prod­uct qual­i­ty, oth­er prod­ucts or man­u­fac­tur­ing com­pa­nies in­volved and any in­for­ma­tion re­lat­ed to the po­ten­tial for or ac­tu­al drug short­age con­cerns.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.